Major Drug Used During Pregnancy Pulled From The Market
Makena from Covis Pharma has been pulled from US markets by the FDA
A pregnancy drug called Makena has been withdrawn from the U.S market. The medication, which claimed to reduce the risk of preterm births, was pulled after its effectiveness could not be proven by the Food and Drug Administration. The drug is a synthetic version of the progesterone hormone required to maintain a pregnancy.
Speaking about the pregnancy drug, Covis Pharma says it stands by its favorable risk-benefit profile. This includes Makena’s efficacy in women with a high risk of preterm birth. “We are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Chief Innovation Officer Doctor Raghav Chari said via CNN Health.
The decision comes four years after pregnancy drug manufacturer Covis Pharma failed to prove that Makena helped women carry babies to term. Since then, the FDA has been trying to get it off the market. The injection symbolizes the agency’s challenges when manufacturers won’t withdraw them without being pushed.
In 2022, an FDA advisory panel voted that the pregnancy drug should be pulled despite the manufacturer’s appeals to keep selling it pending more research. But experts also deemed the shot ineffective and called for its removal. “Allowing it to remain on the market implies the FDA looked at the study, found no benefit, and allowed it to stay,” Doctor Margery Gass told the Associated Press.
“I think that’s a bad precedent,” the obstetrics specialist added. Gass and other doctors encouraged Covis to keep studying the pregnancy drug to determine if some women could benefit. “I think patients deserve an answer,” Doctor Mary Munn said. She added that they also deserve a well-designed clinical trial that can only occur when Makena is off the market.
However, Covis remains convinced that the pregnancy drug works without a trial. Following the committee hearing, the company outlined a plan which would allow existing patients to finish the 21-week course of treatment. But the Center for Drug Evaluation and Research rejected the proposal. As a result, the manufacturer sent a letter to the FDA.
The letter addressed to FDA Commissioner Doctor Robert Califf, and Chief Scientist Dr. Namandje Bumpus said that as the withdrawal moves forward, the company requests that the removal date serve the interests of patients. “Covis is prepared to work with the agency to wind down Makena and its generics from the market,” the pregnancy drug maker said via CNN Health.
Makena has been a popular pregnancy drug in the United States, as 10% of births come before 37 weeks. This increased the risk of severe health problems for infants, including death. In 2011, the FDA granted the accelerated approval based on a small study of women with a history of premature deliveries.
The expedited approval was given the green light after a more extensive follow-up study of 1700 patients to confirm if the pregnancy drug resulted in healthier babies. The results were released in 2019 and showed that the medication didn’t reduce premature births. It also did not result in more beneficial outcomes for infants.
Despite those results, some reproductive specialists have argued for keeping the pregnancy drug available pending research is done. “It is critical that other effective interventions be identified to prevent recurrent preterm birth,” the American College of Obstetricians and Gynecologists said via Fortune.
