Vertex Says FDA approves Kalydeco for use in more than 600 people with CF

Vertex says FDA approves Kalydeco for use in more than 600 people with CF

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Vertex Pharmaceuticals (VRTX) announced that the U.S. FDA has approved #KALYDECO for use in more than 600 people with cystic fibrosis ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator gene.

This approval was based on Phase 3 clinical data for KALYDECO in these mutations and follows the FDA’s approval of KALYDECO in May 2017 for 23 other residual function mutations, which was based on analyses of in vitro data.

Both approvals are supported by more than five years of real-world clinical experience that demonstrate KALYDECO’s established safety and efficacy profile.

RAISED GUIDANCE

Based on today’s approval, Vertex increased its guidance for 2017 KALYDECO product revenues to a range of $770M-$800M.

Vertex’s guidance range for total CF product revenues in 2017 is now $1.87B-$2.1B, including ORKAMBI guidance of $1.1B-$1.3B. KALYDECO is now approved in the U.S. to treat people with CF ages 2 and older who have one of 38 ivacaftor-responsive mutations in the CFTR gene.

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