Mak­e­na saga nears an end as Co­vis re­quests to pull con­tro­ver­sial preterm birth drug

Lux­em­bourg-based Co­vis Phar­ma has been in a tug of war with the FDA over whether to pull its con­tro­ver­sial preterm birth drug Mak­e­na, which won an ac­cel­er­at­ed ap­proval in 2011 but failed its con­fir­ma­to­ry tri­al in 2018.

Af­ter two failed ad­comms, Co­vis is now wav­ing the white flag and agree­ing to pull the drug from the mar­ket, ac­cord­ing to doc­u­ments post­ed this af­ter­noon.

The de­ci­sion from Co­vis fol­lows a 14-1 vote from the FDA’s Ob­stet­rics, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee last Oc­to­ber to pull the drug, which failed to con­firm the drug’s ben­e­fit for ba­bies or moth­ers.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.