Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
John Tlumacki/The Boston Globe/Getty Images
Biogen’s $1.5 billion bet is in the home stretch. On Monday, the Cambridge biotech, along with partner Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
The NDA for zuranolone includes both Major Depressive Disorder (MDD) and Postpartum Depression (PPD), two indications with serious unmet needs.
Sage’s neuroactive steroid is designed as an episodic therapy. If approved, zuranolone would be the first 14-day treatment on the market for depression.
The rapid-acting, episodic nature of the drug is a differentiator for the depression market. With current treatments, patients are prescribed long-term treatments expecting efficacy 6-8 weeks in, Sage Chief Business Officer Chris Benecchi told BioSpace.
In addition to the delayed benefit, common side effects like weight gain and sexual dysfunction often “prevent patients from ultimately getting to the efficacy,” he said.
Biogen and Sage teamed up in late 2020 to jointly develop and commercialize zuranolone. A company representative said the NDA acceptance moves Biogen a step closer to “achieving [its] goal of changing how depression is thought about and treated.”
In 2019, Sage announced zuranolone failed to hit its Phase III primary endpoint for MDD, not distinguishing itself from the placebo on the Hamilton Rating Scale for Depression (HAMD-17).
Jim Doherty, chief development officer at Sage, told BioSpace the “totality of the data is really strong.”
Because it’s not only a new drug but “potentially a very different way of thinking about treating depression,” the clinical program addressed a couple different questions, he said. Data across five other studies for MDD hit primary endpoints and showed a rapid improvement, as early as day three, after the second dose.
Zuranolone garnered more impressive results from its Phase III study in women with PPD. Utilizing HAMD-17, women on the drug saw a mean decrease of 15.6 points on the 17-item scale. Relief in anxiety symptoms appeared as early as day three on the drug and persisted through the 45-day follow-up.
With its priority review status, the FDA has assigned a Prescription Drug User Fee Act action date of Aug. 5.
The potential market for zuranolone is huge. Mental health disorders are among the leading causes of disability and disease burden worldwide, according to Global Burden of Disease’s research efforts.
PPD is one of the most common medical complications during and after pregnancy, affecting approximately one in eight women who have given birth.
Similarly, a 2020 survey estimated 14 million people in the U.S. have been diagnosed with major depressive disorder, with 190 million cases worldwide. These numbers were particularly high due to the global COVID-19 pandemic.
