Valeant gets an FDA OK for new pso­ri­a­sis drug bro­dalum­ab — but there’s a big catch

The FDA has come through with an ap­proval for Valeant’s pso­ri­a­sis drug bro­dalum­ab. But they’ve hob­bled it with a black box safe­ty warn­ing on sui­ci­dal ideation and a risk mit­i­ga­tion mar­ket­ing pro­gram that will like­ly hob­ble its rev­enue in an in­tense­ly com­pet­i­tive mar­ket.

An FDA pan­el al­ready flagged through the drug — to be sold as Siliq — with many of the ex­perts clear­ly more in­ter­est­ed in ob­tain­ing an­oth­er ar­row for their quiver rather than the po­ten­tial safe­ty is­sues, which they felt were man­age­able.

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