The manufacturer of an unverified drug aimed at preventing premature births has announced that it will withdraw the product from the US market voluntarily, following indications from regulators that they intend to proceed with a long-delayed initiative to force it from the market. With this BNN world news, people are curious to know the right reason behind it.
Makena is a synthetic form of the hormone progesterone, which is essential for maintaining a pregnancy and is the only drug that has been authorized by the FDA for decreasing the risk of preterm delivery.
Announcement from Covis Pharma
Covis Pharma has announced that it will voluntarily remove its drug Makena from the US market. This decision comes after the drug failed to demonstrate its effectiveness in preventing premature births four years ago. Despite the FDA’s efforts to withdraw the drug from the market, Covis had appealed for more time to conduct further research. The injectable drug has become a symbol of the challenges that arise when the manufacturer does not voluntarily withdraw a medication. Covis, a Swiss-based company, stated that the extended off-ramp would have provided women who are still undergoing treatment with the drug ample time to complete their course, which includes weekly injections after 16 weeks of pregnancy.
The timing of the removal of Makena, the unproven drug for preventing premature births, is still unclear as the FDA rejected Covis Pharma’s proposal to phase out the drug’s use over several months.
According to the company, the FDA has indicated that it will continue its efforts to remove the drug from the market in its manner, making it unclear when the drug will be removed. In a separate submission on Wednesday, the FDA’s drug regulators suggested that the withdrawal should be “immediately effective.”
The agency stated there is no evidence of “harm from discontinuing Makena, such as signs or symptoms of withdrawal.” The fate of the drug will soon be decided by FDA Commissioner Robert Califf, in consultation with the agency’s leading scientist.
After an October public meeting where outside advisers overwhelmingly concluded that Makena hadn’t been shown to work and should have its approval revoked, Covis proposed the FDA. Despite hours of presentations and debate, the panel was unconvinced by arguments from Covis that the drug can help a subgroup of women. These kinds of hearings are rare and only occur after a drugmaker refuses initial FDA requests to withdraw their drug.
Statement from Covis’ chief information officer
The Covis’ chief information officer, Raghav Chari, stated there is a favorable benefit-risk profile for Makena. It includes the effectiveness in women who are at the highest risk of preterm birth. However, the company has decided to voluntarily withdraw the product and collaborate with the FDA to ensure a systematic phase-out process.
Covis Pharma stated that it is willing to collaborate with the FDA to withdraw the drug, although there is disagreement regarding the timeline. The company also mentioned that it believes in the favorable benefit-risk profile of Makena, including its effectiveness in women at high risk of premature birth.
Premature births affect around 10% of births in the United States, with higher rates among black women, and pose a risk of serious health problems or infant mortality. The FDA granted accelerated approval to Makena in 2011, based on a small study of women with a history of preterm deliveries. However, the approval was conditional on a larger study to confirm the drug’s benefits for healthier outcomes for babies.
The company believes it is vital to identify alternative effective interventions to prevent premature birth recurrence for the health and welfare of patients and their families. This BNN World News story looks promising, and better alternatives may soon be released.