FDA panel vote lifts approval prospects for Sage's Zulresso
- Sage Therapeutics moved a step closer to securing U.S. approval for its postpartum depression (PPD) drug Zulresso after two advisory panels to the Food and Drug Administration on Friday jointly voted 17-1 in favor of the therapy's risk-benefit profile.
- The supporting vote was largely expected, but came with a proviso: committee experts agreed that the injectable drug would be best used through a Risk Evaluation and Mitigation strategy (REMS) program.
- The FDA isn't required to follow the advice of its advisory committees, but usually does. If the agency's decision, expected in December, is similarly positive, Zulresso would become the first drug specifically approved by the FDA for the treatment of PPD.
PPD is the most common medical complication of childbirth and is seen as a distinct major depressive disorder. The condition, which affects as many as 400,000 women each year in the U.S., can be life-threatening due to the increased risk of suicide
Zulresso (brexanolone), if approved, would fill a hole in the current treatment armamentarium. The advisory committees convened Friday together agreed that the drug's benefits outweighed its potential risks.
On safety, panelists voted 16-2 in favor of Zulresso, with discussion mainly centering on six observed cases (out of 140 women treated) of loss of consciousness during infusion of the drug.
In briefing documents made public ahead of the meeting, FDA staff noted that the loss of consciousness didn't appear easily predictable based on variables like dose timing or blood levels. Without a reliable method of predicting the risk of such an event, the review staff recommended the drug be administered through a REMS program.
With the proposed REMS, Zulresso would be administered by qualified staff in a facility certified through the program. How the FDA decides to define that facility could have an impact on the drug's commercial prospects, however.
Zulresso is given in a single infusion over the course of 60 hours, meaning a requirement to administer the drug in a hospital or clinic could be practically challenging for some women.
"Panel discussion did not specify settings that would be appropriate and it was stated that inpatient facilities
do not guarantee risk-free events," wrote Raymond James analyst Laura Chico in a Nov. 2 note to investors. "The conclusion: details need to be worked out. At a minimum, sites will be certified, staff will require training, but specifics on which sites/staff make sense remain [to be determined]."
Zulresso currently holds a Breakthrough Therapy Designation from the FDA, as well as a PRIME designation from the European Medicines Agency for the treatment of PPD. Sage also has another experimental drug, dubbed SAGE-217, in Phase 3 testing for PPD and for major depressive disorder.
The advisory committees' favorable vote for Zulresso comes a day after the panels overwhelmingly voted against recommending approval for an experimental drug for major depressive disorder developed by Alkermes. A final decision from the FDA for that drug is expected in January.
- BioPharma Dive Sage licenses out depression drug in Asia, adding to cash warchest
- BioPharma Dive Sage shares boom on success of postpartum depression drug
Follow Suzanne Elvidge on Twitter