FDA’s independent Obstetrics, Reproductive, and Urologic Drugs Advisory Committee has voted almost unanimously that FDA should withdraw its approval of Makena (hydroxyprogesterone caproate injection). A total of 14 of the 15 committee members supported the withdrawal of the drug. In addition, all of the committee concluded that the postmarket study for Makena did not show a benefit.
Makena is the only FDA-approved therapy with an indication of reducing the risk of preterm birth in pregnant women who have had an earlier spontaneous preterm birth.
The drug has a complicated regulatory history. In 2006, Adeza filed a new drug application for the drug, which was then known as Gestiva. Adeza filed a new drug application for the drug, which was then known as Gestiva. The drug would ultimately end up in the hands of Covis and be rebranded as Makena.
The launch of Makena was delayed until 2011.
A postmarket study would eventually conclude that the drug was ineffective.
FDA advisors’ recommendation to pull the drug from the U.S. market was another blow to the agency’s accelerated approval program. The FDA’s decision to assign Biogen’s Alzheimer’s drug Aduhlem (aducanumab) to the program and ultimately approve the drug in 2021 was another source of controversy. The uptake of aducanumab has fallen far below analysts’ expectations, and Medicare decided to constrain reimbursement of the drug to clinical trial recipients.
However, Raghav Chari, chief innovation officer at Covis, says the company believes that “Makena is effective in a higher-risk patient population,” Chari said in a news release. “We will work collaboratively with the FDA to clarify the next steps in this process.”
Covis estimates that 350,000 women in the U.S. have received the drug in the past decade.
Roughly one in 10 babies born in the U.S. is born preterm, according to The March of Dimes. The rate is higher for diverse populations — affecting 14.2% of Black infants and 11.6% of American Indian/Alaska natives.
Covis Pharma is a private company.
In 2016, Australian researchers discovered that a drug that blocks inflammation pathways prevented early birth in pregnant mice.
Filed Under: Obstetrics & gynecology
