Bur­nish­ing its rare dis­ease drug am­bi­tions, Sanofi picks up fast FDA OK for Ca­blivi — cour­tesy of a $4.8B buy­out

Fol­low­ing up on last fall’s Eu­ro­pean ap­proval for capla­cizum­ab as a new treat­ment for a rare blood dis­ease, Sanofi to­day fol­lowed up with the key to the big mar­ket in the US. The FDA has come through with an OK based on Phase III and Phase II da­ta for ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra (aTTP).

The drug will now hit the mar­ket as Ca­blivi — at a cost of $270,000 per course — af­ter get­ting a pri­or­i­ty re­view at the agency, which is quick at whisk­ing through new drugs when none are ap­proved for a con­di­tion like this.

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