Valeant wins first round in $445M gam­ble on bro­dalum­ab ap­proval

Valeant made an un­usu­al ap­pear­ance in front of an FDA ex­pert pan­el on Tues­day, and came out with a clear en­dorse­ment for an FDA ap­proval of their pso­ri­a­sis drug bro­dalum­ab.

The pan­el vot­ed 18 to 0 in fa­vor of ap­prov­ing bro­dalum­ab, de­spite the agency’s in­ter­nal re­view, which linked the drug to 6 sui­cides and sui­ci­dal ideation as well as car­dio risks. Four of the pan­elists rec­om­mend­ed an ap­proval with noth­ing more than a clear la­bel warn­ing on the risks in­volved, 14 vot­ed yes on an ap­proval with a risk man­age­ment plan in place.

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