The FDA has awarded priority review designation to Sage Therapeutics’ postpartum depression (PPD) drug brexanolone. Securing the status positions Sage to receive a decision from the FDA by the end of the year.
Before the December 19 PDUFA date, the FDA will hold an advisory committee meeting to talk about the submission. If that goes well, Sage could bring its first drug to market around the turn of the year and begin racking up the first sales of what some analysts think will be at least a $500-million-a-year product.
The big question is what the FDA and its advisory committee will make of Sage’s data. Two phase 3 trials linked the intravenous formulation of allopregnanolone to statistically significant improvements on a depression scale, resulting in the studies hitting their primary endpoints. But the details of the data left scope for discussion about the value of the drug, particularly to certain groups of patients.
Brexanolone aced a small phase 2 but its superiority over placebo was less pronounced in the pivotal trials, which recruited 226 patients between them. The divergence was smallest in the phase 3 trial that enrolled patients with moderate, not severe, forms of PPD. In these patients, brexanolone was no more effective than placebo after 30 days.
With Sage’s trial primarily looking at the efficacy of brexanolone after 60 hours, the convergence of depression scores in the treatment and placebo arms after 30 days is a blemish rather than a critical blow. But it is the sort of data point that could come into play as Sage seeks a broad label for brexanolone and then tries to persuade providers and payers to use and cover the drug.
The importance of standout efficacy for Sage commercially is amplified by the burden its drug puts on patients and providers. The version of brexanolone now under review at FDA is administered via a 60-hour infusion. Sage is working on an oral version, but in the near-term, taking brexanolone will be a major commitment.