Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. 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. Kristina Deligiannidis, a principal investigator in the ZURZUVAE clinical development program and Professor, The Feinstein Institutes for Medical Research in Manhasset, New York. “This milestone is hopefully a catalyst for more systemic change for women with PPD including a much-needed increase in screening, diagnosis and treatment across physician specialties.”
“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 New Orleans. “A treatment like ZURZUVAE provides us with a new option to help address the needs of women with PPD.”
Biogen and Sage 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, Biogen and Sage 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 Wendy N. Davis, Ph.D., PMH-C, Executive Director at Postpartum Support International. “PPD should not be treated as an afterthought. We need to embrace the care of women and increase access to effective care. Treatments like ZURZUVAE are a signal of hope that we’re one step closer to prioritizing maternal mental health.”
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 Biogen and Sage 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 committed to working with healthcare providers so women with PPD do not face this isolating condition alone,” said Alisha A. Alaimo, President of Biogen’s North America Organization. “We are proud to offer the first oral therapy indicated specifically for women with PPD and we hope this milestone adds to the growing efforts, federally and among health organizations, to improve maternal mental health care.”
“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 Chris Benecchi, Chief Business Officer at Sage Therapeutics. “Innovations are only impactful if people can access them, and we will continue supporting the goal of broad and equitable access. Our support programs aim, where possible, to help women with PPD who are prescribed ZURZUVAE to have little to no copay, and to provide product at no cost for eligible patients with no insurance, as we believe that lack of insurance or financial means should not be a barrier to treatment access.”