FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder

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Postpartum despair (PPD) approval primarily based on outcomes from two Part 3 scientific trials; within the SKYLARK Research therapy with ZURZUVAE quickly improved signs of PPD at Day 15 and as early as Day 3 with sustained impact to Day 45

Psychological well being situations are the main reason behind maternal mortality¹ with PPD among the many commonest issues throughout and after being pregnant²

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CAMBRIDGE, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) introduced the U.S. Meals and Drug Administration (FDA) authorized ZURZUVAE™ (zuranolone) 50 mg for adults with postpartum despair (PPD). ZURZUVAE is the primary and solely oral, once-daily, 14-day therapy that may present speedy enhancements in depressive signs for ladies with PPD. ZURZUVAE is anticipated to launch and be commercially out there within the fourth quarter of 2023 shortly following scheduling as a managed substance by the U.S. Drug Enforcement Administration, which is anticipated to happen inside 90 days.

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Moreover, the FDA issued a Full Response Letter (CRL) for the New Drug Utility (NDA) for zuranolone within the therapy of adults with main depressive dysfunction (MDD). The CRL acknowledged that the appliance didn’t present substantial proof of effectiveness to help the approval of zuranolone for the therapy of MDD and that a further examine or research might be wanted. Biogen and Sage are reviewing the suggestions and evaluating subsequent steps.

“The approval of ZURZUVAE to deal with postpartum despair is a serious milestone for the tons of of hundreds of ladies who expertise this underdiagnosed and undertreated situation,” mentioned Christopher A. Viehbacher, President and Chief Government Officer at Biogen. “We recognize the help of sufferers, affected person advocates and researchers who helped to achieve this milestone. We consider that ZURZUVAE might be an essential choice to deal with PPD and we’ll totally evaluate the suggestions from the FDA on the usage of zuranolone in MDD to find out subsequent steps.”

“Maternal psychological well being has been sidelined for much too lengthy, however in the present day’s approval of ZURZUVAE helps to alter that. Ladies have been ready for an oral drugs that may particularly and quickly enhance the signs of PPD and we’re proud to have the ability to ship that,” mentioned Barry Greene, Chief Government Officer at Sage Therapeutics. “In regard to the CRL for MDD, we’re extremely dissatisfied for sufferers, notably amid the present psychological well being disaster and hundreds of thousands of individuals with MDD struggling to search out symptom reduction. We stay dedicated to our mission to ship life-changing mind well being medicines.” 

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The approval of ZURZUVAE to deal with ladies with PPD relies on the NEST scientific improvement program, which included two research in grownup ladies with PPD (ROBIN and SKYLARK Research). Each research met their main endpoint, a major imply discount from baseline within the 17-item Hamilton Score Scale for Despair (HAMD-17) whole rating, a standard measure of despair severity, at Day 15 as in comparison with placebo. Within the SKYLARK Research evaluating ZURZUVAE 50 mg, all key secondary endpoints have been met, with vital discount in depressive signs seen as early as Day 3 and sustained via Day 45. ZURZUVAE was typically well-tolerated with a constant security profile throughout each research. The most typical unwanted effects ≥ 5% and higher than placebo in sufferers handled with ZURZUVAE 50 mg have been somnolence, dizziness, diarrhea, fatigue and urinary tract an infection. The labeling features a boxed warning that instructs healthcare suppliers to advise folks that ZURZUVAE causes driving impairment on account of central nervous system (CNS) depressant results. Individuals who take ZURZUVAE shouldn’t drive a motorized vehicle or interact in different probably hazardous actions that require full psychological alertness till no less than 12 hours after ZURZUVAE administration throughout the 14-day therapy course. Sufferers might not have the ability to assess their very own diploma of impairment.

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“Immediately marks a groundbreaking day for the therapy of PPD, as with ZURZUVAE we now have an oral therapy possibility that may present speedy enhancements in depressive signs in as early as three days for ladies with PPD,” mentioned Dr. Kristina Deligiannidis, a principal investigator within the ZURZUVAE scientific improvement program and Professor, The Feinstein Institutes for Medical Analysis in Manhasset, New York. “As a perinatal psychiatrist, I see the devastating influence PPD has on moms notably on the essential mother-infant bond and long-term baby improvement. As soon as out there, I consider ZURZUVAE might be a significant possibility for sufferers in want.”

In keeping with the Facilities for Illness Management and Prevention, psychological well being situations are the main reason behind maternal mortality¹ with PPD among the many commonest issues throughout and after being pregnant.² Within the U.S., it’s estimated roughly 1 in 8 ladies expertise signs of PPD.³ Roughly half of all PPD circumstances might go undiagnosed with out applicable screening.^4,5 Analysis exhibits solely 15.8% of ladies with PPD signs obtain therapy.⁶ PPD signs might persist past the postpartum interval and may result in extended maternal morbidity.^7-9 Signs of PPD can embrace depressed temper, lack of curiosity in actions, adjustments in sleep patterns and urge for food, decreased vitality, emotions of guilt or worthlessness, bother concentrating and in some circumstances ideas of suicide.⁹

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“Immediately’s approval is welcome information for the estimated 500,000 ladies in america who report experiencing signs of this devastating and infrequently misunderstood sickness every year,” mentioned Wendy N. Davis, Ph.D., PMH-C, Government Director at Postpartum Help Worldwide. “Ladies with PPD desperately want immediate care and extra therapy choices that may present fast reduction to allow them to be wholesome and current throughout this momentous time of their lives.”

Indication and Necessary Security Info for ZURZUVAE

What’s ZURZUVAE?
ZURZUVAE is a prescription drugs used to deal with adults with postpartum despair (PPD).
It’s not identified if ZURZUVAE is secure and efficient in youngsters.

IMPORTANT SAFETY INFORMATION
What’s a very powerful data I ought to learn about ZURZUVAE?
ZURZUVAE might trigger severe unwanted effects, together with:

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ZURZUVAE is a federally managed substance (C-XX) as a result of it accommodates zuranolone that may be abused or result in dependence. Hold ZURZUVAE in a secure place to guard it from theft. Don’t promote or give away ZURZUVAE as a result of it might hurt others and is towards the legislation.

Earlier than taking ZURZUVAE, inform your healthcare supplier about your entire medical situations, together with if you happen to:

Females who’re in a position to grow to be pregnant:

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Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. ZURZUVAE and a few medicines might work together with one another and trigger severe unwanted effects. ZURZUVAE might have an effect on the way in which different medicines work and different medicines might have an effect on the way in which ZURZUVAE works.

Particularly inform your healthcare supplier if you happen to take antidepressants, opioids, or CNS depressants resembling benzodiazepines.

What ought to I keep away from whereas taking ZURZUVAE?

See “What’s a very powerful data I ought to learn about ZURZUVAE?”

ZURZUVAE might trigger severe unwanted effects, together with:

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How can I look ahead to and attempt to stop suicidal ideas and actions?

Inform your healthcare supplier immediately in case you have any of the next signs, particularly if they’re new, worse, or fear you:

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The most typical unwanted effects of ZURZUVAE embrace:

These usually are not all the doable unwanted effects of ZURZUVAE. Name your physician for medical recommendation about unwanted effects. You possibly can report unwanted effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information, together with Boxed WARNING, and Medication Guide for ZURZUVAE.

About ZURZUVAE™ (zuranolone)
ZURZUVAE is a once-daily, oral, 14-day drugs for the therapy of adults with postpartum despair (PPD). ZURZUVAE is a neuroactive steroid (NAS) GABA-A receptor optimistic allosteric modulator (PAM). The GABA system is the most important inhibitory signaling pathway of the mind and central nervous system and contributes to regulating mind operate.

About Biogen
Based in 1978, Biogen is a number one international biotechnology firm that has pioneered a number of breakthrough improvements together with a broad portfolio of medicines to deal with a number of sclerosis, the primary authorized therapy for spinal muscular atrophy, and two co-developed therapies to deal with a defining pathology of Alzheimer’s illness. Biogen is advancing a pipeline of potential novel therapies throughout neurology, neuropsychiatry, specialised immunology and uncommon ailments and stays acutely targeted on its objective of serving humanity via science whereas advancing a more healthy, extra sustainable and equitable world.

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We routinely publish data which may be essential to traders on our web site at www.biogen.com. Comply with us on social media – Twitter, LinkedIn, Facebook, YouTube.

About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical firm fearlessly main the way in which to create a world with higher mind well being. Our mission is to pioneer options to ship life-changing mind well being medicines, so each individual can thrive. For extra data, please go to www.sagerx.com.

Biogen Protected Harbor 
This information launch accommodates forward-looking statements, referring to the potential, advantages, security and efficacy of ZURZUVAE; our subsequent steps within the regulatory course of with respect to zuranolone for the therapy of MDD; the potential profit, security and efficacy of ZURZUVAE within the therapy of adults with MDD, if authorized; the potential of Biogen’s business enterprise and pipeline applications, together with ZURZUVAE; the anticipated advantages and potential of Biogen’s collaboration association with Sage; and dangers and uncertainties related to drug improvement and commercialization. These forward-looking statements could also be accompanied by phrases resembling “purpose,” “anticipate,” “consider,” “may,” “estimate,” “count on,” “forecast,” “intend,” “might,” “plan,” “potential,” “doable,” “will,” “would” and different phrases and phrases of comparable which means. Drug improvement and commercialization contain a excessive diploma of threat and solely a small variety of analysis and improvement applications end in commercialization of a product. Ends in early-stage scientific trials might not be indicative of full outcomes or outcomes from later stage or bigger scale scientific trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements, or the scientific knowledge offered. 

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These statements contain dangers and uncertainties that might trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation, uncertainty of success within the improvement and potential commercialization of ZURZUVAE for PPD, and if authorized, for MDD; uncertainty with respect to the regulatory pathway for zuranolone for the therapy of MDD; uncertainty as as to if further research might be required with respect of zuranolone for the therapy of MDD; surprising issues might come up from further knowledge, evaluation or outcomes of scientific research of zuranolone; regulatory authorities might require further data or additional research, or might fail or refuse to approve or might delay approval of Biogen’s drug candidates, together with zuranolone for the therapy of MDD; the prevalence of opposed security occasions; the dangers of different surprising hurdles, prices or delays; failure to guard and implement knowledge, mental property and different proprietary rights and uncertainties referring to mental property claims and challenges; product legal responsibility claims; third social gathering collaboration dangers; and the direct and oblique impacts of COVID-19 on our enterprise, outcomes of operations and monetary situation. The foregoing units forth many, however not all, of the elements that might trigger precise outcomes to vary from Biogen’s expectations in any forward-looking assertion. Buyers ought to contemplate this cautionary assertion in addition to the danger elements recognized in Biogen’s most up-to-date annual or quarterly report and in different reviews Biogen has filed with the U.S. Securities and Alternate Fee. These statements converse solely as of the date of this information launch. Biogen doesn’t undertake any obligation to publicly replace any forward-looking statements.

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Sage Therapeutics Protected Harbor
Varied statements on this launch concern Sage’s future expectations, plans and prospects, together with with out limitation our statements concerning: our expectations as to the timing of completion of DEA scheduling and graduation of deliberate launch, availability and commercialization of ZURZUVAE within the therapy of ladies with PPD; our plans for business launch of ZURZUVAE on this indication; our perception in our readiness for business launch of ZURZUVAE; our plans to judge subsequent steps after receipt of the CRL for zuranolone in MDD; the potential good thing about ZURZUVAE within the therapy of adults with PPD; the variety of ladies with PPD and the potential marketplace for ZURZUVAE for the therapy of ladies with PPD; and the mission and targets for our enterprise. These statements represent forward-looking statements as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements are neither guarantees nor ensures of future efficiency, and are topic to a wide range of dangers and uncertainties, a lot of that are past our management, which may trigger precise outcomes to vary materially from these contemplated in these forward-looking statements, together with the dangers that: our launch and commercialization efforts within the U.S. with respect to ZURZUVAE for the therapy of ladies with PPD might not be profitable, and we could also be unable to generate revenues on the ranges or on the timing we count on or at ranges or on the timing essential to help our targets; the variety of ladies with PPD, the unmet want for added therapy choices, and the potential marketplace for ZURZUVAE on this indication could also be considerably smaller than we count on; ZURZUVAE might not obtain the scientific profit, scientific use or market acceptance we count on within the therapy of ladies with PPD or we might encounter reimbursement-related or different market-related points that influence the success of our commercialization efforts; we might by no means obtain regulatory approval of zuranolone in MDD; the FDA has taken the place that a further scientific trial or scientific trials of zuranolone are required to help approval in MDD and will not change that place; such trial or trials could possibly be time-consuming, considerably improve our bills, and might not be possible; even when we conduct such scientific trials, they might not be profitable; the FDA might resolve that the design, conduct or outcomes of such scientific trials, even when optimistic, usually are not adequate for approval in MDD or might discover different deficiencies in our improvement program, knowledge, processes, or manufacturing websites; even when we obtain regulatory approval of zuranolone for the therapy of MDD, the FDA might approve zuranolone for under a subset of MDD sufferers or with limitations or restrictions; we might encounter opposed occasions for ZURZUVAE at any stage that negatively influence commercialization in ladies with PPD, the potential for regulatory approval in MDD, or if authorized, potential commercialization in MDD; if we run further scientific trials to acquire approval of zuranolone in MDD, we might encounter delays in initiation, conduct, completion of enrollment or completion of any such scientific trials, together with on account of slower than anticipated website initiation, slower than anticipated enrollment, the necessity or determination to broaden the trials or different adjustments, which will influence our means to fulfill our anticipated timelines and improve our prices; selections or actions of the FDA might have an effect on the initiation, timing, design, dimension, progress and price of such scientific trials and our means to proceed with additional improvement or might impair the potential for profitable improvement; the necessity to align with our collaborators might hamper or delay our improvement and commercialization efforts or improve our prices; our enterprise could also be adversely affected and our prices might improve if any of our key collaborators fails to carry out its obligations or terminates our collaboration; and the inner and exterior prices required for our ongoing and deliberate actions, and the ensuing influence on expense and use of money, could also be larger than anticipated which can trigger us to make use of money extra shortly than we count on or to alter or curtail a few of our plans or each; in addition to these dangers extra totally mentioned within the part entitled “Danger Elements” in our most up-to-date quarterly report, in addition to discussions of potential dangers, uncertainties, and different essential elements in our subsequent filings with the Securities and Alternate Fee. As well as, any forward-looking statements signify our views solely as of in the present day and shouldn’t be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to replace any forward-looking statements.

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