FDA will not hold advisory committee meeting on zuranolone NDA

The FDA announced it does not plan to hold an advisory committee meeting on Sage and Biogen’s new drug application for zuranolone to treat major depressive disorder and postpartum depression in adults.

According to a press release from Sage, zuranolone (Sage-217, Biogen) is an investigational oral neuroactive steroid intended as a 14-day, rapid-acting, once-daily treatment.

Zuranolone is currently being evaluated in the LANDSCAPE and NEST clinical development programs, in which the novel therapeutic is being tested in several thousand people with a variety of dosing, clinical endpoints and treatment paradigms. LANDSCAPE includes five studies of zuranolone in those with MDD, and NEST includes two studies of zuranolone in women with PPD.

The NDA application had been granted priority review in early February, and the FDA has assigned a Prescription Drug User Fee Act action date of Aug. 5, the release stated.

According to the FDA website, advisory committees are usually asked for an opinion on whether the study data supports the product’s clearance and they may request further study or labeling changes. However, final product approval lies with the agency.

Reference:

• FDA. Advisory committees: Critical to the FDA’a product review process. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/advisory-committees-critical-fdas-product-review-process. Updated May 4, 2016. Accessed March 8, 2023.