SAGE THERAPEUTICS, INC.
CAMBRIDGE -
ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3.
'For women with PPD, delayed improvement in depressive symptoms can significantly worsen outcomes. Having an option like ZURZUVAE that can work at Day 15 and improve symptoms in as early as three days has the potential to make a profound difference in the lives of women with PPD,' said Dr.
'After having a baby, the post-birth follow-up appointment is usually the first time a woman has the opportunity to talk about how she is feeling. It shouldn't matter if it takes place with her midwife, OBGYN or family practitioner - it's critical we use these conversations to proactively discuss her mental health and take action to support women in need,' said Dr. Quinn Peeper, Obstetrician/Gynecologist at City Crescent Physicians in
Sage and Biogen are prioritizing access through active discussions with national, regional and government payors to advocate for broad and equitable access to ZURZUVAE for women with PPD with minimal restrictions. While coverage decisions by insurers across all payor segments can take time, Sage and Biogen are focused on helping women who are prescribed ZURZUVAE gain access as quickly as possible. The companies also launched a patient support program, ZURZUVAE For You, which provides educational resources, help with understanding insurance coverage, and assistance navigating the prescription fulfillment process. The program also includes financial assistance, such as a copay assistance program, and product at no cost for eligible patients.
The companies are partnering with several of the leading national specialty pharmacies and ZURZUVAE will be shipped directly to women with PPD who are prescribed the treatment.
'It's critical that as a society we recognize PPD is a serious medical condition. I have witnessed the devastating impact untreated PPD can have on women, only heightened by the fact that Black and Brown women and those living in a lower socioeconomic status are disproportionately impacted,' said
PPD symptoms can be debilitating and are characterized by negative changes in mood and impaired function.1,2 PPD impacts women of all races, ethnicity, socio-economic status and community,3-5 though symptoms are more common among minority patient populations compared to white patients.3,4 Black and Brown women, women who live in rural areas, or those on Medicaid may be more likely to receive inadequate postpartum care, compared to individuals in urban areas or with private health insurance.5 Sage and Biogen are working with key stakeholders across states to help raise awareness of the importance of treating PPD rapidly and removing barriers to treatment.
'We are immensely proud of the feedback following the approval of ZURZUVAE from those on the front lines who are advocating for and delivering maternal mental healthcare, as well as their commitment to making an impact collaboratively,' said
'We are committed to working with healthcare providers so women with PPD do not face this isolating condition alone,' said
About ZURZUVAETM (zuranolone)
ZURZUVAE is a once-daily, oral, 14-day medicine for the treatment of adults with postpartum depression (PPD). ZURZUVAE is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.
About
About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, two co-developed treatments to address a defining pathology of Alzheimer's disease, the first treatment to target a genetic form of ALS, the first oral treatment approved for postpartum depression, and the first approved treatment for Friedreich's ataxia. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: our plans for commercializing ZURZUVAE in the treatment of women with PPD; our expectations as to our patient support programs for ZURZUVAE; our goals and plans with respect to access and reimbursement coverage for women with PPD who are prescribed ZURZUVAE; statements regarding the unmet need in the treatment of PPD; our belief in the potential clinical benefit of ZURZUVAE in the treatment of PPD and the mission and goals for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Biogen Safe Harbor
This news release contains forward-looking statements, relating to the potential, benefits, safety and efficacy of ZURZUVAE; the potential of Biogen's commercial business and pipeline programs, including ZURZUVAE; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'potential,' 'possible,' 'will,' 'would' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of ZURZUVAE for PPD; unexpected concerns may arise from additional data, analysis or results of clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks and the direct and indirect impact of COVID-19 on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
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