Biogen’s $1.5B bet for depressive disorders heads to FDA
Biogen’s $1.5B bet for depressive disorders heads to FDA
Biogen’s $1.5B bet for depressive disorders heads to FDA
Published: Feb 06, 2023
By Kate Goodwin
BioSpace
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 a 14-day regimen. Its novel mechanism of action affects patients’ GABA-A receptors.
The rapid-acting effect of the drug is a differentiator for the depression treatment market. Most currently approved therapies for MDD and PPD can take weeks or even months to work, said Laura Gault, M.D., Ph.D., CMO at Sage, in a statement.
Biogen and Sage teamed up in late 2020 to jointly develop and commercialize zuranolone. The deal infused a much needed $875 million cash and $650 million equity investment into Sage, which laid off more than half its workforce earlier that year.
Biogen bought itself exclusive rights to commercialize both zuranolone and another Sage asset for essential tremors outside the U.S., with some exceptions in Asia.
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). The company pointed to a group which showed no measurable drug concentration, suggesting non-compliance in taking the pill. By excluding these patients from the analysis, statistical significance was achieved at all check-in timepoints.
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.
Source: BioSpace