Switzerland-based Covis Pharma announced this week that it has submitted a proposal to withdraw approval of its preterm birth drug, Makena.
Makena was approved in the U.S. in 2011 through the FDA's accelerated approval pathway. However, the approval was conditional on a post-marketing study to confirm its clinical benefit. When the follow-up study failed to demonstrate the drug's efficacy, the FDA's Center for Drug Evaluation and Research (CDER) proposed the withdrawal of the drug's approval in 2020. Covis requested a hearing, which was held in October 2022.
After the meeting, the FDA committee and chief scientist confirmed their decision to withdraw approval for the drug and its generic versions. The committee made their recommendation after considering the results of the post-market confirmatory trial data from the PROLONG study, which were disclosed in October 2019. In the trial, Makena failed to decrease recurrent preterm birth and was not associated with increased or early infant death.
“The 1,708-person confirmatory trial designed to verify Makena’s clinical benefit instead failed to show that Makena has any benefit to newborns,” said the FDA at the time. “Data from this trial, taken together with other evidence, also fail to show that Makena reduces the risk of recurrent preterm birth.” Additionally, the panel pointed out that with Makena on the market, it will likely take a decade or more to complete another trial – but this can happen quicker if the drug is off the market. The panel also noted that, "failure to remove Makena undermines the accelerated approval pathway."
Makena was the only approved drug in the U.S. to treat preterm birth in pregnant patients. In the last few years, its sales decreased significantly, from $322.3 million in 2018 to $122.1 million in 2019.
In response to the FDA’s recommendation, Covis’ chief innovation officer, Raghav Chari, said, “We recognize the attention the agency has directed to this issue, particularly given the complexity around withdrawing a drug with mixed efficacy data and a positive safety profile, and welcome the opportunity to discuss an appropriate wind-down plan for patients.”
