- Sage Therapeutics will have to wait three months longer than expected to hear the Food and Drug Administration's verdict on its postpartum depression drug Zulresso, announcing Tuesday the agency extended its review period.
- A decision is now anticipated by March 19 of next year, rather than the originally scheduled Dec. 19 target action date. The delay stems from the FDA's review of a Risk Evaluation and Mitigation Strategy for Zulresso that Sage proposed on the regulator's recommendation.
- No additional clinical data or information were requested, Sage noted, but that didn't prevent a sell-off Tuesday morning in the company's shares, which dropped by as much as 7.5% in initial trading.
A delayed decision from the FDA means Sage now aims to launch Zulresso (brexanolone), if OK'd, in June instead of late March as investors were expecting.
Approval still looks likely, given the positive recommendation issued earlier this month by an FDA advisory panel on the drug's risk-benefit profile. The agency isn't required to follow the advice of its committees, but usually does.
After any positive decision from the regulator, Zulresso would still need to be scheduled by the Drug Enforcement Administration due to the way in which the drug works.
In response to a request from the FDA, Sage submitted a REMS plan for Zulresso following the early November advisory meeting. As that plan wasn't included in the original New Drug Application, the FDA chose to extend its review by three months to go through the proposal.
REMS plans are used to help manage known safety risks to medicines and can include steps like physician certification or additional patient monitoring.
In the case of Zulresso, concerns centered on a handful of cases of loss of consciousness among the 140 women treated in Sage's pivotal study. The FDA doesn't believe these events are easily predicted through dosing, and recommended qualified staff to administer the drug in a certified facility.
How those terms would be defined for Zulresso is still to be determined, however. The drug is administered via a single infusion given over 60 hours.
If Zulresso is approved, Sage plans to price the drug between $20,000 and $35,000 per treatment course.
Postpartum depression is estimated to affect as many as 400,000 women a year, and there are currently no therapies specifically approved to treat the disorder.