FDA, Regulatory

FDA opts to nail down REMS plan for Sage’s landmark postpartum depression drug, delays final decision

A month before the FDA is scheduled to hand down what many expect to be an OK for Sage Therapeutics’ landmark drug for postpartum depression, the agency says it needs some more time to review a newly submitted risk evaluation and mitigation strategies plan.

The unexpected delay pushes its PDUFA date back three months to March 2019, while the commercialization is now slated to begin in June, Sage said in a statement, likely meaning that the REMS will be in place by the time the drug is rolled out.

Paul Matteis

Sage submitted $SAGE the proposed REMS after the recent advisory committee meeting, where a panel of 18 outside experts voted overwhelmingly for brexanolone’s approval but voiced concerns over safety precautions. Specifically, the experts pointed to unpredictable episodes of unconsciousness observed in 6 out of 140 patients who have so far received the treatment as reason for demanding designated facilities for administration and a 12-hour follow-up to the 60-hour infusion.

While the delay is surprising, it’s not a shock for Stifel’s Paul Matteis, who notes that the FDA’s decision — like the panel discussion — was about “safe use” rather than approvability. The analyst noted:

From our discussions with SAGE, we understand that ahead of the panel the company was uncertain as to whether or not labeling alone would be enough to ensure safe use of brex in the real world. Thus, immediately after a panel that affirmed that a REMS would be needed, SAGE worked to propose a REMS to FDA as quickly as possible. … SAGE believes the rest of the NDA review is on track, and we don’t view the delay as impacting the high probability that the product is approved.

The market, though, is less interested in the strings put on this approval than the understanding they can glean about the FDA’s approach to their oral PPD drug SAGE-217. That drug is the key to unlocking the blockbuster market available here. And so far, so good, with regulators gearing up to review a drug that has — so far — not been tied to the same safety issues.

A batch of Phase III SAGE-217 data will read out in January — a keenly watched event as Sage continues to justify its multibillion-dollar valuation.


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