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.

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