Vertex Gets Speedy FDA Review of Vanza Triple Cystic Fibrosis Therapy
By Colin Kellaher
Vertex Pharmaceuticals has won Food and Drug Administration priority review for its application seeking approval of a triple combination therapy for the genetic lung disease cystic fibrosis.
Vertex on Tuesday said the application covers the once-daily vanzacaftor/tezacaftor/deutivacaftor, or vanza triple, therapy in cystic fibrosis patients ages 6 and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene responsive to the vanza triple.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Boston drugmaker Vertex, which used a priority review voucher for its submission, said the FDA set a target action date of Jan. 2, 2025, for its application.
Vertex also said the European Medicines Agency has validated its application for vanza triple, confirming the submission is complete and beginning the centralized review process.
Vertex noted that vanza triple, if approved, would be subject to a meaningfully lower single-digit royalty obligation compared to the rate payable on its current Vertex's current cystic fibrosis portfolio.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 02, 2024 09:14 ET (13:14 GMT)
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