FDA withdraws approval of Makena

The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma.

This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. The decision was issued jointly by the FDA Commissioner and Chief Scientist. Effective Thursday, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.

The decision comes as no surprise; a month ago, Covis Pharma’s chief innovation officer Raghav Chari issued a statement, saying: “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down. 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.”