Covis Pharma Group, announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s proposal to withdrawal approval for Makena®, the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
Company Has Requested an Orderly Wind-down in Effort to Voluntarily Withdraw Makena®
ZUG, Switzerland, March 07, 2023 (GLOBE NEWSWIRE) -- Covis Pharma Group (“Covis”), today announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s (CDER) proposal to withdrawal approval for Makena® (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous 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.
“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,” said Raghav Chari, PhD, Chief Innovation Officer at Covis. “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.”
Covis remains ready to work cooperatively with the agency to confirm an orderly wind-down and withdrawal of Makena and its generics. Given CDER’s acknowledgement at the hearing that Makena does not have significant safety concerns and that an immediate withdrawal would be disruptive to patients in the middle of an indicated course of treatment, the company respectfully requests that once any final order is issued, the effective date be set to allow for a wind-down that would best serve the interests of patients.
As the company awaits a final decision by the FDA, Makena remains approved and the product label is unchanged at this time.
About Covis Pharma Group
Covis Pharma Group, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.
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