FDA hits No­vo Nordisk with CRL for its once-dai­ly he­mo­phil­ia drug con­cizum­ab

No­vo Nordisk had to find a “new path for­ward” for its he­mo­phil­ia A and B drug back in 2020 af­ter halt­ing sev­er­al stud­ies be­cause of pa­tient blood clots — and it hit a new snag in the form of a com­plete re­sponse let­ter from the FDA.

The FDA on April 24 sent the com­pa­ny a CRL for con­cizum­ab, its once-dai­ly mon­o­clon­al an­ti­body aim­ing to stop ex­ces­sive bleed­ing events be­fore they hap­pen, ac­cord­ing to its most re­cent earn­ings re­port on Thurs­day. No­vo Nordisk sub­mit­ted the drug for reg­u­la­to­ry ap­proval in the US for the treat­ment of he­mo­phil­ia A and B with in­hibitors last year.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER