Vertex's CF Three-Drug Combo Excels In Phase III, But Filing Depends On Second Regimen's Results
Vertex duplicated promising efficacy observed in Phase II for its cystic fibrosis triple combo that includes VX-659, but wants to see data expected in early 2019 for a triplet containing VX-445 before filing for approvals.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Already dominant in cystic fibrosis, Vertex hopes its triple regimen will address roughly 90% of the patient population. It also hopes the benefits of the triple will smooth EU reimbursement talks.
Two three-drug regimens for cystic fibrosis hit their primary endpoints in both heterozygous and homozygous patients, with good safety and tolerability, which analysts say increases the likelihood one of them will obtain approval.