The US Food and Drug Administration (FDA) has approved the once-daily oral Zurzuvae (zuranolone) for the treatment of postpartum depression.
Biogen plans to launch Zurzuvae in the last quarter of 2023 in the US, following the US Drug Enforcement Administration’s scheduling of Zurzuvae as a controlled substance, as per the company’s press release.
Zurzuvae is a neuroactive steroid (NAS) gamma-aminobutyric acid type A (GABA-A) receptor-positive allosteric modulator (PAM), which acts on the GABA-inhibiting pathway to regulate brain function.
The drug is being co-developed by Sage Therapeutics and Biogen as part of a global collaboration and licence agreement for Zurzuvae and SAGE-324. As part of the deal, both companies will share Zurzuvae’s developmental costs and revenues in the US while Biogen will hold these rights outside the US, excluding Japan, Taiwan, and South Korea.
The approval for Zurzuvae is based on the two randomised placebo-controlled Phase III trials (NCT02978326 and NCT04442503). Both the studies met their primary endpoints by achieving a reduction in the depression assessment scale, Hamilton Rating Scale for Depression (HAMD-17), at day 15, compared to the baseline.
The most common side effects associated with Zurzuvae are somnolence or sleepiness, dizziness, diarrhoea, fatigue, and urinary tract infection.
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The approval news for Zurzuvae was accompanied by a disclosure that Biogen received a complete response letter (CRL) regarding the therapy’s new drug application (NDA) in another indication, major depressive disorder (MDD). The FDA response cited the need for an additional trial or multiple studies to for generating evidence on Zurzuvae’s efficacy.
Last month, Biogen announced the high-profile acquisition of Reata Pharmaceuticals for $7.3bn. The latter’s pipeline includes Skyclarys (omaveloxolone), the only FDA-approved treatment for the genetic neuromuscular disorder Friedreich’s Ataxia.
In the press release, Postpartum Support International executive director Wendy N Davis: “[Zurzuvae] approval is welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year.”