Makena, an unproven drug to prevent premature births, to be pulled from US market
The company behind Makena, an unproven drug intended to prevent premature births, said it will voluntarily remove the product from the U.S. market.
The announcement Tuesday from Switzerland-based Covis Pharma comes roughly four years after Makena failed to show a benefit in helping mothers carry pregnancies to term.
Since then the Food and Drug Administration has been moving to get the drug off the market, though Covis has repeatedly appealed for more time to conduct additional research. The injectable drug has become a symbol for the challenges the FDA faces to withdraw a medication when the manufacturer won't do so voluntarily.
About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. The problem occurs at higher rates among Black women.
Here's what we know.
What is Makena?
Makena is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. The treatment involves weekly injections starting after 16 weeks of pregnancy.
It's the only drug with FDA approval to reduce the risk of premature birth.
More:The rate of babies born premature saw a 'concerning' increase in 2021
Background:FDA panel recommends pulling Makena, citing ineffectiveness
Why is Makena being taken off the market?
The FDA granted Makena accelerated approval in 2011 based on a small study in women with a history of early deliveries. The expedited approval was conditioned on a larger follow-up study to confirm whether the drug resulted in healthier outcomes for babies.
In 2019, results from that 1,700-patient international study showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.
In 2020, the FDA proposed removing Makena from the market. Covis, in turn, requested a rare hearing to make its case for keeping the drug on the market. In October, the FDA's advisory panel, made up of gynecologists, obstetricians and other fetal medicine experts, voted to withdraw Makena, citing recent study results that showed it did not prevent health problems in newborns of mothers who took the drug.
What's next?
The timing of the drug's removal is unclear. FDA Commissioner Robert Califf is expected to soon decide on the drug's fate, in consultation with the agency's top scientist.
Covis said that FDA regulators rejected its proposal to wind down the drug's use over several months. That extended off-ramp would give women who are still receiving the drug time to finish their course of treatment, the company said.
But the FDA made clear it would continue its internal process to force the drug's removal on its own terms, according to the company.
"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, Covis' chief information officer, in a statement.
The company added that it "remains ready to work cooperatively with the agency," to remove the drug, despite disagreement on the timeframe.