Makena, the only drug the Food and Drug Administration (FDA) has authorized for preterm birth prevention, will no longer be available for sale.
This decision was made after an expert panel from the FDA recommended for the withdrawal of the drug.
This voluntary market pullout comes from the FDA's recommendation last year, stating that a significant study conducted in 2019 found no proof of the drug's effectiveness.
Covis Pharma agrees to the removal of Makena
The maker of an unproven drug called Makena, meant to prevent preterm births, has announced that it will voluntarily take the product off the U.S. market.
According to CBS, this decision comes after the regulators indicated they would finally act on their long-delayed efforts to force it off the market.
Makena is a synthetic form of the hormone progesterone essential to maintaining a pregnancy. It is the only drug the FDA has approved to reduce the risk of premature birth.
However, Makena failed to prove its effectiveness in helping mothers carry pregnancies to full term four years ago.
Since then, the FDA has been trying to remove the drug from the market, but Covis Pharma, the manufacturer, has repeatedly asked for more time to conduct additional research. The injectable drug has become a symbol of the difficulties the FDA faces in removing a medication when the manufacturer does not voluntarily withdraw it.
Covis Pharma, based in Switzerland, said that the FDA regulators rejected its proposal to wind down the drug's use over several months gradually.
The company suggested that the extended timeline would allow women still taking the drug to complete their course of treatment, which involves weekly injections starting at 16 weeks of pregnancy.
Makena is the only preterm drug on the market
Makena is a synthetic version of the hormone progesterone used to maintain a pregnancy and reduce the risk of preterm birth.
According to FiercePharma, the drug was approved by the FDA in 2011 under accelerated approval, allowing it to be marketed before its confirmatory trial.
However, the drug failed to show a benefit in helping mothers carry pregnancies to term in the trial conducted by the drug's manufacturer.
Following the trial's failure, the FDA's advisory committee voted to recommend sidelining Makena, citing its lack of efficacy.
Despite this, Covis Pharma, a Swiss-based pharmaceutical company, has been fighting to keep it on the market.
Covis repeatedly appealed for more time to conduct additional research, arguing that the trial was biased towards white European women and did not reflect the benefits black women in the US had experienced with the injected treatment.
The debate surrounding Makena has divided doctors on whether to continue prescribing the treatment.
Some doctors argued that the drug still had value in preventing preterm births, while others suggested that it should be removed from the market due to its lack of efficacy.
Furthermore, The Washington Post reported that roughly 10 percent of all births in the United States are preterm, meaning they occur before 37 weeks.
Black and Native American women are 62 percent more likely than white women to experience preterm births. These preterm births have been linked to various adverse outcomes, such as asthma, sudden infant death syndrome, and hearing and vision impairments.
The planned withdrawal of the drug from the market is the latest development in a years-long controversy at the intersection of science, racial health disparities, and pharmaceutical profits.
