Drug to Prevent Preterm Births to Be Pulled From Market
Makena was the only drug approved by the FDA to reduce the risk of preterm birth in women with a history of early deliveries.
Photo:
Eric Lee for The Wall Street Journal
Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.
Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.
Makena is a synthetic version of the hormone progesterone.
Photo:
Covis Pharma/Associated Press
“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 Covis Chief Innovation Officer
Raghav Chari.
Makena, a weekly injection, is a synthetic version of the hormone progesterone. It was intended to help women avoid early births, which can result in babies with severe health problems.
The drug was at the center of a long-running saga that tested the agency’s program to speed drugs to market under a program known as accelerated approval.
The FDA gave Makena accelerated approval in 2011, requiring its maker to confirm its benefit in more studies. In 2019, however, Makena failed to work in the follow-up trial, and the FDA began to move to pull the drug from the market.
Write to Liz Essley Whyte at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Makena was the only drug approved by the FDA to reduce the risk of preterm birth in women with a history of early deliveries.
Photo:
Eric Lee for The Wall Street Journal
Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.
Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.
Makena is a synthetic version of the hormone progesterone.
Photo:
Covis Pharma/Associated Press
“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 Covis Chief Innovation Officer
Raghav Chari.
Makena, a weekly injection, is a synthetic version of the hormone progesterone. It was intended to help women avoid early births, which can result in babies with severe health problems.
The drug was at the center of a long-running saga that tested the agency’s program to speed drugs to market under a program known as accelerated approval.
The FDA gave Makena accelerated approval in 2011, requiring its maker to confirm its benefit in more studies. In 2019, however, Makena failed to work in the follow-up trial, and the FDA began to move to pull the drug from the market.
Write to Liz Essley Whyte at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Denial of responsibility! Techno Blender is an automatic aggregator of the all world’s media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, all materials to their authors. If you are the owner of the content and do not want us to publish your materials, please contact us by email – [email protected]. The content will be deleted within 24 hours.