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# Vertex Gains Priority Review Voucher
- URL: https://www.fdaweb.com/vertex-gains-priority-review-voucher/
- Published: 2019-03-29T12:00:00.000Z
- Updated: 2026-09-15T01:16:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143739

*Federal Register* notice: FDA has awarded Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. The agency recently approved the company’s Symdeko (tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to tezacaftor/ivacaftor based on *in vitro* data or clinical evidence. The agency determined that the therapy meets criteria for a priority review voucher. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-29/pdf/2019-06138.pdf?ref=fdaweb.com).