Covis Pharma Group has requested an orderly wind-down in an effort to voluntarily withdraw Makena, the only FDA-approved treatment to reduce the risk of preterm birth.

Covis appreciates the opportunity it was afforded to present its view that relevant safety and efficacy data continue to support the approval of Makena, at least in a narrower indication. Nevertheless, Covis respects the recommendations of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, and, in light of its recommendations, is seeking to voluntarily withdraw the Makena NDA.

Shortly after the hearing, Covis outlined a plan for voluntary withdrawal that would have obviated the need for further proceedings. The request included a wind-down period that would allow current patients to complete their 21-week course of treatment and for only remaining inventory to be exhausted. CDER was not in agreement with the proposal, and requested that the proceedings continue until concluded with a decision from the FDA Commissioner and Chief Scientist.

Makena’s 2011 approval was based on a trial run by the National Institutes of Health that showed the drug, a synthetic hormone called hydroxyprogesterone caproate, helped prevent early labor in women with a prior history of delivering before full-term. But its clearance was conditional on further study proving its benefit.

Results from that confirmatory trial, released in 2019 and long after they were originally due, showed Makena did not prevent preterm births or improve the health of newborns. An advisory committee later recommended removing the drug from market and, one year later, FDA staff proposed its withdrawal.