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Vertex’s Orkambi Approved With Broad Label For Cystic Fibrosis

Quick launch is planned, with firm having prepared ‘at risk of having a successful approval’ – patient screening and reimbursement shepherding are early areas of focus.

FDA advisory committee panelists weren’t greatly concerned about whether Orkambi clearly offered greater therapeutic benefit than Kalydeco monotherapy and the agency apparently agreed, approving Vertex Pharmaceuticals Inc.’s fixed-dose combination for cystic fibrosis July 2 with as broad a label as the sponsor likely could have anticipated.

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