Only Drug to Prevent Premature Births Will Be Pulled from U.S. Market

The maker of the only drug approved to reduce the risk of premature labor in the U.S. wants to pull it off the market—gradually—years after research raised questions about how well it works. Apollo Global Management’s Covis Pharma Group said it is trying to withdraw Makena in an orderly fashion after a U.S. Food and Drug Administration advisory panel recommended retracting its approval at a meeting in October. While the medicine had won accelerated approval in 2011, a subsequent study intended to confirm its benefits found it didn’t work better than older drugs. An FDA division proposed pulling the drug from the market in 2020 based on its conclusion that the study didn’t show Makena was effective for its intended use. [time-brightcove not-tgx=”true”] The situation is adding to the controversy around expedited approvals in the U.S., which allow experimental drugs to be given to patients based on preliminary data that suggests they will have a significant benefit. The follow up research required to validate those expectations is often delayed, studies show, meaning patients are at risk of being exposed to questionable treatments for years. Read More: You Can Do Everything ‘Right’ and Still Have a Preterm Birth Makena’s immediate withdrawal would be disruptive to patients who are currently in the middle of the 21 week course of treatment, the company said in a statement, noting that it doesn’t have any significan...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized bloomberg wire Drugs healthscienceclimate Source Type: news