FDA fast track review for trust-backed Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE), a high conviction idea for two of the biotech sector specialist investment trusts, has confirmed that the US FDA has accepted the NDA filing for its lead product, brexanolone IV for treatment of postpartum (post natal) depression (PPD), and granted the application priority review status. NDA acceptance is a small, but important first step in the drug’s regulatory review.
Sage is an important holding for two of the main sector specialists trusts: Swiss-listed BB Biotech (BBB.S, 4.6% of NAV) and London-listed International Biotechnology Trust (IBT, 3.7% of NAV).
The FDA has set itself a target review completion date of 19 December. Sage also disclosed that the FDA will also convene an advisory committee meeting, which would normally take place a month or two before this target review date. The “AdCom” is an outside panel of physicians assembled to discuss the application in a public forum and make a recommendation on approval by way of a vote. The FDA is not required to follow this advice, but usually would do so. The AdCom means also investors have an opportunity to consider the briefing documents, which are published a couple of days ahead of the meeting.
If approved, brexanolone would be the first medication specifically indicated for the treatment of PPD and would be Sage’s first commercial product. The FDA grants Priority Review to investigational therapies that may offer significant improvements in the treatment, prevention or diagnosis of serious conditions. PPD is the most common medical complication of childbirth affecting a subset of women typically commencing in the third trimester of pregnancy or in the months after giving birth. In the US, some 8-20% of new mothers are thought to suffer from PPD.
Sage has completed two Phase III trials for brexanolone that evaluated the safety and effectiveness in moderate and severe PPD. These studies enrolled women aged between 18 and 45 years, who were ≤6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery. In both trials at all doses, brexanolone achieved the primary endpoint, namely a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score at 60 hours compared to placebo.
Analysts project near blockbuster sales potential for brexanolone in PPD.