FDA Forces the Only Drug for Preterm Births to Leave Market

Makena’s manufacturer, Covis Pharma Group, last month said it would withdraw the medication voluntarily but requested a wind-down period.

“The touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” said FDA Commissioner Dr.

Robert Califf

in a statement.

The weekly injection for pregnant women who previously have had early births is a synthetic version of the hormone progesterone. It was the only FDA-approved drug on the market intended to help prevent preterm deliveries, which can lead to major health problems for newborns.

The FDA first approved Makena in 2011 using an accelerated process that required the manufacturer to demonstrate in follow-up studies that the drug worked. But Makena failed its follow-up study in 2019, and FDA advisers twice voted in favor of pulling it from the market. 

The drug’s manufacturer had argued that it may be beneficial for Black women, who have a higher risk for preterm birth and who weren’t well-represented in the follow-up study that the drug failed.

Covis had requested that the FDA work with it to determine a wind-down period for the drug that would allow women currently taking the drug to finish the 21-week therapy. But Dr. Califf, in Thursday’s decision, sided with agency scientists who wanted the drug removed from the market immediately.

Makena comes with possible side effects, including blood clots, depression and allergic reactions. Covis said previously that the drug has a strong safety record and that adverse events are rare, but the FDA has said some evidence suggests there may be long-term risks that aren’t yet well understood.

Covis earlier said it still believed the drug’s benefits outweighed the risks but didn’t promise future clinical trials to prove that. It had argued that persuading patients to join such a trial, using a drug widely known to be removed from the market, would be difficult.

Makena was viewed by some legal experts as a test of whether the agency had enough teeth to enforce the terms of its accelerated approval process when drugs don’t work. Some drugs fail or never complete their follow-up trials, including some cancer drugs. The agency typically nudges manufacturers to withdraw drugs voluntarily, and it is rare for the agency to force a withdrawal. 

Write to Liz Essley Whyte at [email protected]

Makena’s manufacturer, Covis Pharma Group, last month said it would withdraw the medication voluntarily but requested a wind-down period.

“The touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” said FDA Commissioner Dr.

Robert Califf

in a statement.

The weekly injection for pregnant women who previously have had early births is a synthetic version of the hormone progesterone. It was the only FDA-approved drug on the market intended to help prevent preterm deliveries, which can lead to major health problems for newborns.

The FDA first approved Makena in 2011 using an accelerated process that required the manufacturer to demonstrate in follow-up studies that the drug worked. But Makena failed its follow-up study in 2019, and FDA advisers twice voted in favor of pulling it from the market. 

The drug’s manufacturer had argued that it may be beneficial for Black women, who have a higher risk for preterm birth and who weren’t well-represented in the follow-up study that the drug failed.

Covis had requested that the FDA work with it to determine a wind-down period for the drug that would allow women currently taking the drug to finish the 21-week therapy. But Dr. Califf, in Thursday’s decision, sided with agency scientists who wanted the drug removed from the market immediately.

Makena comes with possible side effects, including blood clots, depression and allergic reactions. Covis said previously that the drug has a strong safety record and that adverse events are rare, but the FDA has said some evidence suggests there may be long-term risks that aren’t yet well understood.

Covis earlier said it still believed the drug’s benefits outweighed the risks but didn’t promise future clinical trials to prove that. It had argued that persuading patients to join such a trial, using a drug widely known to be removed from the market, would be difficult.

Makena was viewed by some legal experts as a test of whether the agency had enough teeth to enforce the terms of its accelerated approval process when drugs don’t work. Some drugs fail or never complete their follow-up trials, including some cancer drugs. The agency typically nudges manufacturers to withdraw drugs voluntarily, and it is rare for the agency to force a withdrawal. 

Write to Liz Essley Whyte at [email protected]