What’s going to happen to AMAG Pharmaceuticals?
Yesterday, AMAG Pharmaceuticals sat through a daylong FDA panel to determine whether Makena, a drug meant to prevent premature birth, should stay on the market. And the result, while undeniably negative, still leaves plenty of questions for the company.
The panelists resoundingly voted no when asked whether Makena had demonstrated a benefit over placebo, but the question over whether it should be pulled from shelves was more complicated. Nine of the 16 panelists recommended the FDA revoke the drug’s approval, while the rest recommended the Makena stay on the market with the condition that AMAG run another trial that confirms a benefit.
The agency’s final decision could be informed by factors well outside of AMAG’s control. As Cowen analyst Ken Cacciatore has pointed out, despite the controversy over Makena’s effects, there remains a strong demand from clinicians and patients. And if AMAG’s product is yanked off the market, the only available version of the drug would come from compounding pharmacies, which are spottily regulated.
The panelists resoundingly voted no when asked whether Makena had demonstrated a benefit over placebo, but the question over whether it should be pulled from shelves was more complicated. Nine of the 16 panelists recommended the FDA revoke the drug’s approval, while the rest recommended the Makena stay on the market with the condition that AMAG run another trial that confirms a benefit.
The agency’s final decision could be informed by factors well outside of AMAG’s control. As Cowen analyst Ken Cacciatore has pointed out, despite the controversy over Makena’s effects, there remains a strong demand from clinicians and patients. And if AMAG’s product is yanked off the market, the only available version of the drug would come from compounding pharmacies, which are spottily regulated.
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