Ahead of Friday’s advisory committee panel on Sage Therapeutics’ $SAGE brexanolone, FDA reviewers recommended that the postpartum depression drug be administered in the presence of a healthcare professional outside the patient’s home.
The agency’s main concern with the drug formerly known as SAGE-547 was with an observed loss of consciousness during infusion, which occurred in 6 of 140 women exposed to brexanolone. After evaluating the dose, blood level, concurrent medications, available medical history, and patient characteristics, FDA reviewers found no relationship between these factors and the occurrence of LOC, making the event unpredictable.
“We therefore recommend implementing a risk evaluation and mitigation strategy (REMS) to improve the safety of the drug product,” they wrote in the report. The company hopes to have it administered at home.
Evidence of brexanolone’s efficacy was derived from three studies, each showing the drug induced an improvement in depressive symptoms as measured by the Hamilton depression scale 60 hours following brexanolone infusion versus placebo. But the agency also appeared unsure about how to analyze the efficacy of the higher 90 μg/kg/h dose versus the 60 μg/kg/h dose, noting that placebo-subtracted difference in HAM-D scores for the two doses are consistent with the efficacy results of other, approved antidepressants.
Nevertheless they noted should brexanolone win its expected approval, “it would be in the best interest of public health to have it widely available to the relevant patient population.”
PPD is considered a life-threatening condition because patients carry a risk of suicide. The disorder affects 1 in 9 women in the United States, according to the CDC, and has profound negative effects on the maternal-infant bond and later infant development. Although there are a number of existing antidepressants in the market, none are specifically approved for PPD and there is little evidence of their efficacy in this condition.
Sage is also developing an oral PPD drug called SAGE-217, potentially worth billions in a form that is free of brexanolone’s 60-hour infusion, but pivotal data are not expected until later this year.
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