Covis Pharma to voluntarily withdraw preterm birth prevention drug from market

Key takeaways :

• Covis Pharma will voluntarily withdraw its preterm birth prevention drug Makena from the market.
• An FDA advisory committee in October voted to recommend withdrawal due to ineffectiveness.

Covis Pharma Group has submitted a response to the presiding officer’s report on the FDA advisory committee hearing on the proposal to withdrawal approval for a preterm birth prevention drug, according to a press release.

Currently, hydroxyprogesterone caproate injection (Makena, Covis Pharma) is the only FDA-approved treatment to reduce preterm birth risk in pregnant women who have previously had spontaneous preterm birth. As Healio previously reported, FDA advisers in October recommended withdrawing hydroxyprogesterone caproate injection from the market in a 14-1 vote due to lack of effectiveness.

“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,” Raghav Chari, PhD, chief innovation officer at Covis, said in the release.

Covis outlined a plan for voluntary withdrawal after the FDA advisory committee hearing to end further proceedings. This plan includes a wind-down period allowing current patients to finish their 21-week treatment course and for remaining inventory to be used. However, the Center for Drug Evaluation and Research did not agree to this proposal and requested continued proceedings until a decision from the FDA commissioner and chief scientist is made.

“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,” Chari said.

Until a final decision is made by the FDA, hydroxyprogesterone caproate injection will remain approved with an unchanged product label.