9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`m e n u
`
`H o m e > M e d i a C e n t e r >
`
`P r e s s R e l e a s e s
`
`U.S. FDA APPROVES EISAI'S DAYVIGO™ (LEMBOREXANT) FOR THE
`TREATMENT OF INSOMNIA IN ADULT PATIENTS
`Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials
`of Nearly 2,000 Paents
`
`T Y P E
`
`P r e s s R e l e a s e
`
`W O O D C L I F F L A K E , N . J . , D e c . 2 3 , 2 0 1 9 / P R N e w s w i r e / - - E i s a i
`
`D e c e m b e r 2 3 , 2 0 1 9
`
`
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`D A T E R E L E A S E D
`
`
`
`SUBSCRIBE TO OUR
`NEWS
`
`Email
`
`s u b m i t
`
`I n c . , t h e U . S . p h a r m a c e u t i c a l s u b s i d i a r y o f E i s a i C o . , L t d . , t o d a y
`
`a n n o u n c e d t h e U . S . F o o d a n d D r u g A d m i n i s t r a t i o n ( F D A )
`
`a p p r o v e d D A Y V I G O ™ ( l e m b o r e x a n t ) 5 m g a n d 1 0 m g f o r t h e
`
`t r e a t m e n t o f a d u l t p a t i e n t s w i t h i n s o m n i a , c h a r a c t e r i z e d b y
`
`d i f f i c u l t i e s w i t h s l e e p o n s e t a n d / o r s l e e p m a i n t e n a n c e .
`
`1
`
` T h e
`
`a p p r o v a l w a s b a s e d o n a r o b u s t c l i n i c a l d e v e l o p m e n t p r o g r a m
`
`t h a t i n c l u d e d t w o p i v o t a l P h a s e 3 s t u d i e s , w h i c h e v a l u a t e d
`
`D A Y V I G O v e r s u s p l a c e b o f o r u p t o o n e m o n t h a n d D A Y V I G O
`
`v e r s u s p l a c e b o f o r s i x m o n t h s . T h e F D A h a s r e c o m m e n d e d t h a t
`
`D A Y V I G O b e c l a s s i f i e d a s a c o n t r o l l e d s u b s t a n c e , a n d t h i s
`
`r e c o m m e n d a t i o n h a s b e e n s u b m i t t e d t o t h e U . S . D r u g
`
`E n f o r c e m e n t A d m i n i s t r a t i o n ( D E A ) . D A Y V I G O w i l l b e
`
`c o m m e r c i a l l y a v a i l a b l e f o l l o w i n g s c h e d u l i n g b y t h e D E A , w h i c h
`
`i s e x p e c t e d t o o c c u r w i t h i n 9 0 d a y s .
`
`" I n s o m n i a d i s o r d e r i s a c h r o n i c c o n d i t i o n t h a t h a s a v a r i e t y o f
`
`p o t e n t i a l n e g a t i v e i m p a c t s a n d l o n g - t e r m c o n s e q u e n c e s f o r
`
`h e a l t h a n d w e l l - b e i n g , "
`
`2
`
`s a i d R u s s e l l R o s e n b e r g , P h D , D . A B S M , a
`
`p r i n c i p a l i n v e s t i g a t o r i n t h e D A Y V I G O c l i n i c a l s t u d i e s a n d
`
`f o r m e r C h a i r m a n o f t h e B o a r d o f t h e N a t i o n a l S l e e p F o u n d a t i o n .
`
`" T h e c l i n i c a l t r i a l s p r o v i d e e v i d e n c e t h a t D A Y V I G O m a y i m p r o v e
`
`p a t i e n t s ' a b i l i t y t o f a l l a s l e e p a n d s t a y a s l e e p . "
`
`T h e m o s t c o m m o n a d v e r s e r e a c t i o n ( r e p o r t e d i n 5 % o r m o r e o f
`
`p a t i e n t s t r e a t e d w i t h D A Y V I G O a n d a t l e a s t t w i c e t h e r a t e o f
`
`p l a c e b o ) i n S t u d y 1 ( t h e f i r s t 3 0 d a y s ) a n d S t u d y 2 w a s
`
`s o m n o l e n c e ( D A Y V I G O 1 0 m g , 1 0 % ; D A Y V I G O 5 m g , 7 % ; p l a c e b o ,
`
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 1/9
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`Page 1 of 9
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`EISAI EXHIBIT 1021
`
`

`

`9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`1 . 0 % ) . T h e m o s t c o m m o n a d v e r s e r e a c t i o n s l e a d i n g t o
`
`d i s c o n t i n u a t i o n o f D A Y V I G O w e r e s o m n o l e n c e ( D A Y V I G O 1 0 m g ,
`
`1 . 0 % ; D A Y V I G O 5 m g , 0 . 7 % ; p l a c e b o , 0 . 4 % ) a n d n i g h t m a r e s
`
`( D A Y V I G O 1 0 m g , 0 . 3 % ; D A Y V I G O 5 m g , 0 . 3 % ; a n d p l a c e b o , 0 % ) .
`
`1
`
`T h e F D A a p p r o v a l w a s b a s e d o n f i n d i n g s f r o m t h e l e m b o r e x a n t
`
`c l i n i c a l d e v e l o p m e n t p r o g r a m , i n c l u d i n g t w o p i v o t a l P h a s e 3
`
`s t u d i e s – S t u d y 1 a n d S t u d y 2 :
`
`Study 1 was a six-month, randomized, double-blind, placebo-controlled, mul-center
`trial in adult paents age 18 or older who met DSM-5 criteria for insomnia disorder.
`Paents were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO
`10 mg (n=323) once nightly. The primary ecacy endpoint was the mean change from
`baseline to end of treatment at six months for log-transformed, paent-reported
`(subjecve) sleep onset latency (sSOL; the esmated minutes from the me that the
`paent aempted to sleep unl sleep onset). Pre-specied secondary ecacy
`endpoints for sleep maintenance were change from baseline to end of treatment at six
`months for paent-reported sleep eciency (sSEF; the proporon of me spent asleep
`per me in bed) and wake aer sleep onset (sWASO; the minutes of wake from the
`onset of sleep unl wake me). The primary and pre-specied secondary ecacy
`endpoints were measured by sleep diary. In Study 1, DAYVIGO 5 mg and 10 mg
`demonstrated stascally signicant superiority on the primary ecacy measure,
`sSOL, compared to placebo. DAYVIGO 5 mg and 10 mg also showed stascally
`signicant superiority in sSEF and sWASO.
`1
`Study 2 was a one-month randomized, double-blind, placebo- and acve-controlled,
`mul-center, parallel-group clinical trial in adult female paents age 55 and older and
`male paents 65 years and older who met DSM-5 criteria for insomnia disorder.
`Paents were randomized to placebo (n=208), DAYVIGO 5 mg (n=266) or 10 mg
`(n=269), or acve comparator (n=263) once nightly. The primary ecacy endpoint was
`the mean change in log-transformed latency to persistent sleep (LPS; the number of
`minutes from lights o to the rst 10 consecuve minutes of non-wakefulness) from
`baseline to end of treatment (Days 29/30), as measured by overnight polysomnography
`(PSG) monitoring. The pre-specied secondary ecacy endpoints in Study 2 were the
`mean change from baseline to end of treatment (Days 29/30) in sleep eciency (SEF)
`and wake aer sleep onset (WASO) measured by PSG. In Study 2, DAYVIGO 5 mg and
`10 mg demonstrated stascally signicant superiority on the primary ecacy
`measure, LPS, compared to placebo. DAYVIGO 5 mg and 10 mg demonstrated
`stascally signicant improvement in SEF and WASO compared to placebo.
`1
`The eects of DAYVIGO at the beginning of treatment were generally consistent with
`later mepoints.
`
`I n 1 2 - m o n t h a n d o n e - m o n t h c o n t r o l l e d s a f e t y a n d e f f i c a c y t r i a l s
`
`( S t u d i e s 1 a n d 2 , r e s p e c t i v e l y ) , D A Y V I G O w a s n o t a s s o c i a t e d
`
`w i t h r e b o u n d i n s o m n i a f o l l o w i n g t r e a t m e n t
`
`d i s c o n t i n u a t i o n .
`
`1
`
` W i t h d r a w a l e f f e c t s w e r e a l s o a s s e s s e d b y t h e
`
`T y r e r B e n z o d i a z e p i n e W i t h d r a w a l S y m p t o m Q u e s t i o n n a i r e
`
`f o l l o w i n g d i s c o n t i n u a t i o n f r o m s t u d y d r u g i n p a t i e n t s w h o
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 2/9
`
`Page 2 of 9
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`9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`r e c e i v e d D A Y V I G O 5 m g o r 1 0 m g .
`
`1
`
` T h e r e w a s n o e v i d e n c e o f
`
`w i t h d r a w a l e f f e c t s f o l l o w i n g D A Y V I G O d i s c o n t i n u a t i o n a t e i t h e r
`
`d o s e .
`
`1
`
`I n a d d i t i o n t o t h e s e p i v o t a l t r i a l s , E i s a i c o n d u c t e d a n u m b e r o f
`
`s t u d i e s t o f u r t h e r e v a l u a t e t h e s a f e t y o f D A Y V I G O , i n c l u d i n g a
`
`d r i v i n g s t u d y a n d a s t u d y t h a t a s s e s s e d t h e e f f e c t o f D A Y V I G O
`
`o n p o s t u r a l s t a b i l i t y a n d m e m o r y p e r f o r m a n c e .
`
`Middle-of-the-Night Safety: The eect of DAYVIGO on middle-of-the-night safety was
`evaluated in a randomized, placebo- and acve-controlled trial in healthy female
`subjects ≥ 55 years or male subjects ≥ 65 years. Postural stability, the ability to awaken
`in response to a sound smulus, and aenon and memory were assessed following a
`scheduled awakening four hours aer the start of the eight-hour me in bed. Nighme
`dosing of DAYVIGO 5 mg and 10 mg resulted in impairment of balance (measured by
`body sway area) at four hours as compared to placebo. There were no meaningful
`dierences between DAYVIGO (5 mg or 10 mg) and placebo on ability to awaken to
`sound. DAYVIGO was associated with dose-dependent worsening on measures of
`aenon and memory as compared to placebo. Paents should be cauoned about the
`potenal for middle-of-the-night postural instability, as well as aenon and memory
`impairment.
`1
`Eects on Next-Day Postural Stability and Memory: The eects of DAYVIGO on next-
`day postural stability and memory were evaluated in two randomized, placebo- and
`acve-controlled trials in healthy subjects and insomnia paents age 55 and older.
`There were no meaningful dierences between DAYVIGO (5 mg or 10 mg) and placebo
`on next-day postural stability or memory compared to placebo.
`1
`Eects on Driving: A randomized, double-blind, placebo- and acve-controlled, four-
`period crossover study evaluated the eects of nighme administraon of DAYVIGO
`on next-morning driving performance approximately nine hours aer dosing in 24
`healthy elderly subjects (≥65 years, median age 67 years; 14 men, 10 women) and 24
`adult subjects (median age 49 years; 12 men, 12 women). The primary driving
`performance outcome measure was change in Standard Deviaon of Lane Posion
`(SDLP). Tesng was conducted aer one night (a single dose) and aer eight
`consecuve nights of treatment with DAYVIGO. Although DAYVIGO at doses of 5 mg
`and 10 mg did not cause stascally signicant impairment in next-morning driving
`performance in adult or elderly subjects (compared with placebo), driving ability was
`impaired in some subjects taking 10 mg DAYVIGO. Paents using the 10 mg dose
`should be cauoned about the potenal for next-morning driving impairment because
`there is individual variaon in sensivity to DAYVIGO.
`1
`
`" W e b e l i e v e t h e a p p r o v a l o f D A Y V I G O i s p a r t i c u l a r l y e x c i t i n g
`
`b e c a u s e i t i s t h e f i r s t F D A - a p p r o v e d m e d i c a t i o n t o r e p o r t s a f e t y
`
`d a t a o v e r a 1 2 - m o n t h p e r i o d a l o n g w i t h s l e e p o n s e t a n d s l e e p
`
`m a i n t e n a n c e e f f i c a c y d a t a o v e r a s i x - m o n t h p e r i o d i n a p i v o t a l
`
`c l i n i c a l s t u d y , " s a i d L y n n K r a m e r , M D , C h i e f C l i n i c a l O f f i c e r ,
`
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 3/9
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`Page 3 of 9
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`9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`N e u r o l o g y B u s i n e s s G r o u p , E i s a i . " W e l o o k f o r w a r d t o m a k i n g
`
`t h i s n e w t h e r a p e u t i c o p t i o n a v a i l a b l e t o t h e m i l l i o n s o f p a t i e n t s
`
`w h o s u f f e r w i t h i n s o m n i a . "
`
`" D A Y V I G O i s a n i m p o r t a n t a d d i t i o n t o E i s a i ' s r a p i d l y g r o w i n g
`
`n e u r o l o g y p o r t f o l i o a n d u n d e r s c o r e s o u r l e a d e r s h i p i n
`
`n e u r o s c i e n c e , " s a i d I v a n C h e u n g , C h a i r m a n a n d C E O , E i s a i I n c .
`
`a n d G l o b a l P r e s i d e n t , N e u r o l o g y B u s i n e s s G r o u p , E i s a i C o . , L t d .
`
`" O u r c o m m i t m e n t t o p a t i e n t s a n d t h e i r f a m i l i e s d r i v e s o u r
`
`r e l e n t l e s s p u r s u i t o f i n n o v a t i v e h e a l t h c a r e s o l u t i o n s . "
`
`T h e F u l l P r e s c r i b i n g I n f o r m a t i o n i s a v a i l a b l e h e r e .
`
`< N o t e s t o e d i t o r s >
`
`1 . A b o u t L e m b o r e x a n t
`
`L e m b o r e x a n t i s a s m a l l - m o l e c u l e c o m p o u n d , d i s c o v e r e d a n d
`
`d e v e l o p e d b y E i s a i i n - h o u s e s c i e n t i s t s , t h a t i n h i b i t s o r e x i n
`
`s i g n a l i n g b y b i n d i n g c o m p e t i t i v e l y t o b o t h o r e x i n r e c e p t o r
`
`s u b t y p e s ( o r e x i n r e c e p t o r 1 a n d 2 ) . I n i n d i v i d u a l s w i t h n o r m a l
`
`d a i l y s l e e p - w a k e r h y t h m s , o r e x i n s i g n a l i n g i s b e l i e v e d t o
`
`p r o m o t e p e r i o d s o f w a k e f u l n e s s . I n i n d i v i d u a l s w i t h s l e e p - w a k e
`
`d i s o r d e r s , i t i s p o s s i b l e t h a t o r e x i n s i g n a l i n g t h a t r e g u l a t e s
`
`w a k e f u l n e s s i s n o t f u n c t i o n i n g n o r m a l l y .
`
`I N D I C A T I O N
`
`D A Y V I G O ( l e m b o r e x a n t ) i s a n o r e x i n r e c e p t o r a n t a g o n i s t
`
`i n d i c a t e d f o r t h e t r e a t m e n t o f a d u l t p a t i e n t s w i t h i n s o m n i a ,
`
`c h a r a c t e r i z e d b y d i f f i c u l t i e s w i t h s l e e p o n s e t a n d / o r s l e e p
`
`m a i n t e n a n c e .
`
`I M P O R T A N T S A F E T Y I N F O R M A T I O N
`
`C O N T R A I N D I C A T I O N S
`
`DAYVIGO is contraindicated in paents with narcolepsy.
`
`W A R N I N G S A N D P R E C A U T I O N S
`
`Central Nervous System (CNS) Depressant Eects and Dayme Impairment:
`DAYVIGO can impair dayme wakefulness. CNS depressant eects may persist in
`some paents up to several days aer disconnuing DAYVIGO. Prescribers should
`advise paents about the potenal for next-day somnolence.
`
`Driving ability was impaired in some subjects taking DAYVIGO 10 mg. Risk of dayme
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 4/9
`
`Page 4 of 9
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`9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`impairment is increased if DAYVIGO is taken with less than a full night of sleep
`remaining or at a higher than recommended dose. If taken in these circumstances,
`paents should not drive or engage in acvies requiring mental alertness.
`
`Use with other classes of CNS depressants increases the risk of CNS depression.
`Dosage adjustments of DAYVIGO and concomitant CNS depressants may be necessary
`when administered together. Use of DAYVIGO with other insomnia drugs is not
`recommended. Paents should be advised not to consume alcohol in combinaon with
`DAYVIGO.
`
`Because DAYVIGO can cause drowsiness, paents, parcularly the elderly, are at a
`higher risk of falls.
`
`Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinaons, and Cataplexy-Like
`Symptoms:
`Sleep paralysis, hypnagogic/hypnopompic hallucinaons, and symptoms similar to mild
`cataplexy can occur with the use of DAYVIGO. Prescribers should explain these events
`to paents.
`
`Complex Sleep Behaviors:
`Complex sleep behaviors have been reported to occur with the use of hypnocs such
`as DAYVIGO. Events can occur in hypnoc-naïve and hypnoc-experienced persons.
`Paents usually do not remember these events. Complex sleep behaviors may occur
`following the rst or any subsequent use of DAYVIGO, with or without the
`concomitant use of alcohol and other CNS depressants. Disconnue DAYVIGO
`immediately if a paent experiences a complex sleep behavior.
`
`Paents with Compromised Respiratory Funcon:
`The eect of DAYVIGO on respiratory funcon should be considered for paents with
`compromised respiratory funcon. DAYVIGO has not been studied in paents with
`moderate to severe obstrucve sleep apnea (OSA) or chronic obstrucve pulmonary
`disease (COPD).
`
`Worsening of Depression/Suicidal Ideaon:
`Incidence of suicidal ideaon or suicidal behavior, as assessed by quesonnaire, was
`0.3% for DAYVIGO 10 mg, 0.4% for DAYVIGO 5 mg, and 0.2% for placebo. In primarily
`depressed paents treated with hypnocs, worsening of depression and suicidal
`thoughts and acons (including completed suicides) have been reported. Suicidal
`tendencies may be present in such paents and protecve measures may be required.
`Intenonal overdose is more common in this group of paents; therefore, the lowest
`number of tablets that is feasible should be prescribed at any one me. The emergence
`of any new behavioral sign or symptom of concern requires careful and immediate
`evaluaon.
`
`Need to Evaluate for Co-Morbid Diagnoses:
`Treatment of insomnia should be iniated only aer careful evaluaon of the paent.
`Re-evaluate for comorbid condions if insomnia persists or worsens aer 7 to 10 days
`of treatment.
`
`A D V E R S E R E A C T I O N S
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 5/9
`
`Page 5 of 9
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`

`9/28/2020
`
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`The most common adverse reacon (reported in 5% of paents treated with DAYVIGO
`and at least twice the rate of placebo) with DAYVIGO was somnolence (10% for
`DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, 1% for placebo).
`
`D R U G I N T E R A C T I O N S
`
`CYP3A inhibitors: The maximum recommended dose of DAYVIGO is 5 mg no more
`than once per night when co-administered with weak CYP3A inhibitors. Avoid
`concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors.
`
`CYP3A inducers: Avoid concomitant use of DAYVIGO with moderate or strong CYP3A
`inducers.
`
`U S E I N S P E C I F I C P O P U L A T I O N S
`
`Pregnancy and Lactaon: There is a pregnancy exposure registry that monitors
`pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy.
`Healthcare providers are encouraged to register paents in the DAYVIGO pregnancy
`registry by calling 1-888-274-2378. There are no available data on DAYVIGO use in
`pregnant women to evaluate for a drug-associated risk of major birth defects,
`miscarriage or adverse maternal or fetal outcomes.
`
`There are no data on the presence of lemborexant in human milk, the eects on the
`breased infant, or the eects on milk producon. Infants exposed to DAYVIGO
`through breastmilk should be monitored for excess sedaon.
`
`Geriatric Use: Exercise cauon when using doses higher than 5 mg in paents ≥65
`years old.
`
`Renal impairment: Paents with severe renal impairment may experience an increased
`risk of somnolence.
`
`Hepac impairment: The maximum recommended dose of DAYVIGO is 5 mg in
`paents with moderate hepac impairment. DAYVIGO is not recommended in paents
`with severe hepac impairment. Paents with mild hepac impairment may experience
`an increased risk of somnolence.
`
`D R U G A B U S E A N D D E P E N D E N C E
`
`Controlled substance scheduling of DAYVIGO is pending review by the U.S. Drug
`Enforcement Administraon (DEA).
`Because individuals with a history of abuse or addicon to alcohol or other drugs may
`be at increased risk for abuse and addicon to DAYVIGO, follow such paents
`carefully.
`
`F o r m o r e i n f o r m a t i o n a b o u t D A Y V I G O , s e e f u l l P r e s c r i b i n g
`
`I n f o r m a t i o n .
`
`2 . A b o u t S l e e p D i s o r d e r s
`
`P o p u l a t i o n s t u d i e s s h o w t h a t s l e e p d i s o r d e r s a f f e c t m a n y m o r e
`
`p e o p l e w o r l d w i d e t h a n p r e v i o u s l y t h o u g h t .
`
`3
`
` I n s o m n i a s y m p t o m s
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`a f f e c t a p p r o x i m a t e l y 3 0 % o f t h e a d u l t p o p u l a t i o n w o r l d w i d e .
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`4
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 6/9
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`9/28/2020
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`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`I n s o m n i a d i s o r d e r i s c h a r a c t e r i z e d b y d i f f i c u l t y f a l l i n g a s l e e p ,
`
`s t a y i n g a s l e e p o r b o t h , d e s p i t e a n a d e q u a t e o p p o r t u n i t y t o
`
`s l e e p , w h i c h c a n l e a d t o d a y t i m e c o n s e q u e n c e s , s u c h a s f a t i g u e ,
`
`d i f f i c u l t y c o n c e n t r a t i n g a n d i r r i t a b i l i t y .
`
`2 , 5
`
`S l e e p i n g w e l l i s e s s e n t i a l f o r g o o d h e a l t h , i n c l u d i n g b r a i n
`
`h e a l t h . P o o r s l e e p i s a s s o c i a t e d w i t h a w i d e r a n g e o f h e a l t h
`
`c o n s e q u e n c e s .
`
`2
`
`E x p e r i m e n t a l s t u d i e s i n a n i m a l s a n d h u m a n s p r o v i d e e v i d e n c e o f
`
`a s s o c i a t i o n s b e t w e e n s l e e p a n d d i s e a s e r i s k f a c t o r s , d i s e a s e s
`
`a n d m o r t a l i t y .
`
`6
`
` S t u d i e s s u g g e s t a n o p t i m a l s l e e p d u r a t i o n
`
`b e t w e e n s e v e n a n d e i g h t h o u r s .
`
`7
`
`W o m e n a r e 1 . 4 t i m e s m o r e l i k e l y t h a n m e n t o s u f f e r f r o m
`
`i n s o m n i a .
`
`8
`
` O l d e r a d u l t s a l s o h a v e a h i g h e r p r e v a l e n c e o f
`
`i n s o m n i a ; a g i n g i s o f t e n a c c o m p a n i e d b y c h a n g e s i n s l e e p
`
`p a t t e r n s , i n c l u d i n g d i s r u p t e d s l e e p , f r e q u e n t w a k i n g , a n d e a r l y
`
`w a k i n g , t h a t c a n l e a d t o l e s s s l e e p t i m e .
`
`9
`
`3 . A b o u t E i s a i I n c .
`
`A t E i s a i I n c . , h u m a n h e a l t h c a r e ( h h c ) i s o u r g o a l . W e g i v e o u r
`
`f i r s t t h o u g h t s t o p a t i e n t s a n d t h e i r f a m i l i e s , a n d h e l p i n g t o
`
`i n c r e a s e t h e b e n e f i t s h e a l t h c a r e p r o v i d e s . A s t h e U . S .
`
`p h a r m a c e u t i c a l s u b s i d i a r y o f T o k y o - b a s e d E i s a i C o . , L t d . , w e
`
`h a v e a p a s s i o n a t e c o m m i t m e n t t o p a t i e n t c a r e t h a t i s t h e d r i v i n g
`
`f o r c e b e h i n d o u r e f f o r t s t o d i s c o v e r a n d d e v e l o p i n n o v a t i v e
`
`t h e r a p i e s t o h e l p a d d r e s s u n m e t m e d i c a l n e e d s .
`
`E i s a i i s a f u l l y i n t e g r a t e d p h a r m a c e u t i c a l b u s i n e s s t h a t o p e r a t e s
`
`i n t w o g l o b a l b u s i n e s s g r o u p s : o n c o l o g y a n d n e u r o l o g y
`
`( d e m e n t i a - r e l a t e d d i s e a s e s a n d n e u r o d e g e n e r a t i v e d i s e a s e s ) . O u r
`
`U . S . h e a d q u a r t e r s , c o m m e r c i a l a n d c l i n i c a l d e v e l o p m e n t
`
`o r g a n i z a t i o n s a r e l o c a t e d i n N e w J e r s e y ; o u r d i s c o v e r y l a b s a r e
`
`i n M a s s a c h u s e t t s a n d P e n n s y l v a n i a ; a n d o u r g l o b a l d e m a n d c h a i n
`
`o r g a n i z a t i o n r e s i d e s i n M a r y l a n d a n d N o r t h C a r o l i n a . T o l e a r n
`
`m o r e a b o u t E i s a i I n c . , p l e a s e v i s i t u s a t w w w . e i s a i . c o m / U S a n d
`
`f o l l o w u s o n T w i t t e r a n d L i n k e d I n .
`
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 7/9
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`9/28/2020
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`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`
`R e f e r e n c e s
`
` E i s a i I n c . D A Y V I G O F u l l P r e s c r i b i n g I n f o r m a t i o n . 2 0 1 9 .
`
` I n s t i t u t e o f M e d i c i n e . S l e e p d i s o r d e r s a n d s l e e p d e p r i v a t i o n :
`
`1 2
`
`A n u n m e t p u b l i c h e a l t h p r o b l e m . W a s h i n g t o n , D C : N a t i o n a l
`
`A c a d e m i e s P r e s s . 2 0 0 6 .
`
`3
`
` F e r r i e J E , e t a l . S l e e p e p i d e m i o l o g y – a r a p i d l y g r o w i n g f i e l d .
`
`I n t J E p i d e m i o l . 2 0 1 1 ; 4 0 ( 6 ) : 1 4 3 1 – 1 4 3 7 .
`
`4
`
` R o t h T . I n s o m n i a : d e f i n i t i o n , p r e v a l e n c e , e t i o l o g y a n d
`
`c o n s e q u e n c e s . J C l i n S l e e p M e d . 2 0 0 7 ; 3 ( 5 S u p p l ) : S 7 – S 1 0 .
`
`5
`
` O h a y o n M M , e t a l . E p i d e m i o l o g y o f i n s o m n i a : w h a t w e k n o w
`
`a n d w h a t w e s t i l l n e e d t o l e a r n . S l e e p M e d R e v . 2 0 0 2 ; 6 ( 2 ) : 9 7 -
`
`1 1 1 .
`
`6
`
`C a p p u c c i o F P , e t a l . S l e e p a n d c a r d i o - m e t a b o l i c d i s e a s e . C u r r
`
`C a r d i o l R e p . 2 0 1 7 ; 1 9 : 1 1 0 .
`
`7
`
` C a p p u c c i o F P , e t a l . S l e e p d u r a t i o n a n d a l l - c a u s e m o r t a l i t y : a
`
`s y s t e m a t i c r e v i e w a n d m e t a - a n a l y s i s o f p r o s p e c t i v e s t u d i e s .
`
`S l e e p . 2 0 1 0 ; 3 3 ( 5 ) : 5 8 5 - 5 9 2 .
`
`8
`
` R o t h T , e t a l . P r e v a l e n c e a n d p e r c e i v e d h e a l t h a s s o c i a t e d w i t h
`
`i n s o m n i a b a s e d o n D S M - I V - T R ; I n t e r n a t i o n a l S t a t i s t i c a l
`
`C l a s s i f i c a t i o n o f D i s e a s e s a n d R e l a t e d H e a l t h P r o b l e m s , t e n t h
`
`r e v i s i o n ; a n d R e s e a r c h D i a g n o s t i c C r i t e r i a / I n t e r n a t i o n a l
`
`C l a s s i f i c a t i o n o f S l e e p D i s o r d e r s , s e c o n d e d i t i o n c r i t e r i a :
`
`r e s u l t s f r o m t h e A m e r i c a I n s o m n i a S u r v e y . B i o l
`
`P s y c h i a t r y . 2 0 1 1 ; 6 9 : 5 9 2 – 6 0 0 .
`
`9
`
` C r o w l e y K . S l e e p a n d s l e e p d i s o r d e r s i n o l d e r
`
`a d u l t s . N e u r o p s y c h o l R e v . 2 0 1 1 ; 2 1 ( 1 ) : 4 1 - 5 3 .
`
`C o n t a c t :
`
`E i s a i I n c .
`
`L i b b y H o l m a n
`
`2 0 1 - 7 5 3 - 1 9 4 5
`
`l i b b y _ h o l m a n @ e i s a i . c o m
`
`S O U R C E E i s a i I n c .
`
`RECENT RELEASES
`
`Sep 10, 2020
`Sep 20, 2020
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`Aug 28, 2020
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 8/9
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`Page 8 of 9
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`9/28/2020
`U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients - Dec 23, 2019
`MERCK AND EISAI PRESENT FIRST-TIME
`EISAI TO PRESENT NEW DATA
`EISAI PRESENTS NEW ANALYSES FROM
`DATA FROM TWO STUDIES EVALUATING
`HIGHLIGHTING KEYTRUDA®
`PHASE 3 STUDIES OF DAYVIGO™
`KEYTRUDA® (PEMBROLIZUMAB) PLUS
`(PEMBROLIZUMAB) PLUS LENVIMA®
`(LEMBOREXANT) CIV FOR THE
`LENVIMA® (LENVATINIB) IN SEVEN
`(LENVATINIB) INVESTIGATIONAL
`TREATMENT OF INSOMNIA IN ADULT
`DIFFERENT TUMOR TYPES AT ESMO
`COMBINATION THERAPY AND ERIBULIN
`PATIENTS AT VIRTUAL SLEEP 2020
`VIRTUAL CONGRESS 2020
`PLATFORM AT ESMO 2020
`
`This is the website of Eisai Inc., a US company. This site is intended for US residents...
`
`https://eisai.mediaroom.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients#:~:text=U.S. FDA Approves Eisai's DAYVIGO,Adult Patients - Dec 23… 9/9
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`Page 9 of 9
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