Regulatory Accelerated approvals to confirmatory trials: the journey of Makena

Accelerated approvals to confirmatory trials: the journey of Makena


More than a decade ago in 2011, the Food and Drug Authority (FDA) granted accelerated approval to Makena, a drug used to treat recurrent preterm birth, after it showed positive results in around a 450 people trial called Meis study or Trial 002. Another reason for granting conditional approval was that then, and even now, this was the only drug available on the market to help women who had a medical history of pre-term birth.

The FDA acknowledges that the drug is important because the condition puts mothers and children at risk, and disproportionately affects women of color and those from poor socioeconomic backgrounds. The agency can also not deny that based on most recent data, from 2018 studies, the drug has proven to be ineffective in mitigating health concerns and does not have a favorable benefit-risk profile.

Treatment by Makena has failed to reduce neonatal morbidity and mortality, there is also no significant evidence present to suggest that any of the benefits advertised for the product have held true.

Under these circumstances, FDA has called to rescind the approval of the drug. For this purpose, a 3-day trial session will be held which will be led by a team of 16 OB-GYNs and experts. In these sessions both Covis Pharma, the company producing the drug as well as the FDA will each be allowed a day of examination and cross-examination after which voting will be held on whether or not the drug should remain on the market. 

The panel will be allowed to question both parties all days and at the end of the trial, advisors will deliver a note of their opinion. FDA, however, is not bound by it and the final decision will be that of agency chief scientist Namandjé Bumpus and FDA Commissioner Robert Califf.

The verdict of these sessions will be a testament to the power of the FDA when it comes to withdrawing approval for drugs that have failed to present desirable results in confirmatory trials without which it is feared that the process for these accelerated approvals will be undermined. 

The process is already heavily criticized by academics and legislators and in the words of Sara Rothman, J.D., M.P.H., of the FDA’s Center for Drug Evaluation and Research (CDER), “In order for the system to work the approval has to act as a two-way street, in order to protect public health and patients a balance has to be drawn between approvals and withdrawals.”

In order to mitigate these concerns, Covis had shared that it is willing to conduct additional tests such as a randomized trial of around 400 participants but this process will take up to 6 years approximately. Rather than an outright withdrawal of the drug, the company suggests that consumption can be limited to the most at-risk patients. The company has also promised to stop active advertisements for the drug.

Makena was originally owned by Amag Pharmaceuticals and Covis only became the drug’s sponsor in 2021. From 2018-2021, sales from the drug have reached $700 million from Medicare and Medicaid alone.

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