[Printed in IBD on 4 Sept.] This Biotech's Drug Had No 'Red Flags' In Study — Will FDA Panel Agree?
ALLISON GATLIN9/04/2018
Sage Therapeutics' ( SAGE) experimental postpartum depression treatment didn't produce any "red flags" in recent tests, an analyst said Tuesday.
This is important ahead of a Food and Drug Administration advisory committee meeting, RBC Capital Markets analyst Brian Abrahams said in a note to clients. The meeting will determine whether the benefits of Sage's brexanolone outweigh potential risks, he said.
"Overall, we did not find any 'red flags' that would substantially change our view of brexanolone's approvability," he wrote. But there are "some potential hints as to what could be the key discussion topics at an upcoming November FDA panel," he added
Brexanolone looks approvable as a postpartum depression treatment, he said. The drug improved insomnia and there were no new or emerging side effects. Blended Phase 2 and Phase 3 data show statistically significant benefits across all time points.
Before the FDA considers approving it in December, brexanolone will go before a panel of experts who will weigh the drug's merits.
Sedative Qualities Of Postpartum Depression Treatment It's likely those experts will zero in on brexanolone's sedative qualities, Abrahams said. About 4% of patients had "excessive sedation," and some lost consciousness. But there was no change to their vital signs and all regained consciousness.
"We believe the FDA will view this as along the spectrum of sleeping pills and acceptable, given the severity of postpartum depression — which would be a topic of focus at the panel with respect to monitoring/scheduling of the drug," he said.
The panel may also worry about brexanolone as an at-home infusion, as well as its durability. At a one point in the study, the number of placebo patients who reached remission was actually higher than those treated with brexanolone.
"Still, this was not the primary endpoint (goal), achieving benefits rapidly vs. waiting a month remains key in the disease," he said. Further, he noted that this particular outcome was likely an outlier and "the overall effects are likely durable."
On the stock market today, Sage stock ended the regular trading session flat, at 164.29. Shares are consolidating with a buy point at 188.92.
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