Introduced in 2011, Makena was approved under the accelerated approval pathway to ‘reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth’.
An injection given every seven days by a healthcare provider, Makena is administered between 16 weeks and 20 weeks, 6 days of your pregnancy.
Since 2018 the U.S. has spent $700 million on Makena through various government programs, including Medicaid.
In 2019 an international study of 1,700 patients showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.
This caused the medical community to question whether it should be on the market at all if there was no benefit to moms or babies.
On October 5, 2020, The Center for Drug Evaluation and Research submitted a proposal to the U.S. Food and Drug Administration (FDA) to withdraw the agency’s accelerated approval for the drug following concerns about its effectiveness.
The FDA granted a hearing and on October 14, 2020, Covis Pharma Group sought an additional 30 days in which to submit data and information in support.
Covis Pharma argued that Makena benefits women at the highest risk of early deliveries, including Black Americans, and proposed narrowing its approval to that group while it conducted another study to confirm effectiveness. They argued that removing Makena would worsen racial disparities in prenatal care.
The Makena website notes that 350,000 women have used the drug in the last decade.
On Wednesday, October 19th, 2022 the Food and Drug Administration’s advisory panel voted 14-1 that Makena should be withdrawn, despite appeals from the manufacturer to keep it available pending additional research.
“If we allow Makena to remain on the market, it implies the FDA looked at a large study, found no benefit and yet allowed this drug to stay on the market,” said Dr. Margery Gass, an obstetrics specialist. “I think that’s a bad precedent.”
In the next few months, FDA Commissioner Dr. Robert Califf is expected to make a final decision on whether the drug will be withdrawn. If pulled, it would be the first time the FDA has removed a drug that it initially approved based on promising early data.
