FDA puts its foot down on Makena: New meta-analysis does not change call to pull the drug
A recently published meta-analysis of 31 randomized, controlled trials on the premature birth drug Makena is not changing the FDA’s previous decision to pull its accelerated approval and remove it from the market, the agency said late last week.
The FDA’s decision to publicly critique the meta-analysis is the latest twist in a saga that most recently involved the FDA proposing to withdraw the accelerated approval of Makena, almost a decade since it first won approval, after a large, randomized confirmatory trial failed to show the drug’s benefit for newborns or its ability to reduce the risk of pre-term birth.
In discussing the meta-analysis, the agency took issue with how it grouped different trials together, and how only five of the 31 trials evaluated Makena in the indicated population and compared it with placebo.
“The EPPPIC meta-analysis grouped together HPC [hydroxyprogesterone caproate] trials of patients with differences in their risk profiles, including combining women with a prior PTB [pre-term birth] and those without a prior PTB, and women with and without a short cervix. Because of this grouping, the meta-analysis does not provide relevant information regarding Makena’s effectiveness for its approved use,” the agency said Friday.
The FDA also said that it never would have approved Makena in the first place had it known what was in the data from the confirmatory trial.
Despite the clarity from the agency, one of the companies that makes Makena is not backing down.
Covis previously requested a hearing with the FDA (the agency hasn’t decided yet whether to hold a hearing) to discuss the situation. Covis CEO Michael Porter said in a statement that the firm is “seeking the opportunity to discuss data-driven next steps, including further evaluating real-world data.”
AMAG reported more than $40 million in Makena revenue over the first two quarters of last year.
The FDA noted that Makena and its approved generic versions will continue to remain on the market until the manufacturers decide to remove the drugs or the FDA commissioner mandates their removal.