Nearly two years after an FDA advisory panel determined Covis Pharma’s controversial premature-birth med Makena should be taken off the market after failing a key post-approval study, the agency is giving the company a chance to plead its case.
The US Food and Drug Administration is standing by its October 2020 recommendation that Makena (intramuscular17-hydroxyprogesterone caproate, or 17-OHPC) be withdrawn from the market, notwithstanding a new meta-analysis of the efficacy of progestogens for prevention of preterm birth.
WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA’s Notice of Opportunity for a Hearing (“NOOH”) regarding the Agency’s proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.
The Food and Drug Administration on Monday said the only drug approved to prevent preterm birth hasn't been shown to be effective and should be removed from the market.
The US Food and Drug Administration (FDA) on Monday proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a postmarket study failed to confirm clinical benefit.
An FDA group recommended Amag's drug Makena should be removed from the market after it failed a follow-up study.
Luxembourg-based Covis Group is set to acquire Massachusetts-based AMAG Pharmaceuticals in a new deal worth approximately $647 million on an enterprise basis, including debt, it has emerged.