- Longer-term follow-up data demonstrate consistent and durable response to treatment - BOSTON --(BUSINESS WIRE)--Dec. 11, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced two oral presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition from
-Phase 3 study met primary endpoint and all secondary endpoints- -Study is a U.S. post-marketing commitment and will be submitted to FDA- -Data also will be submitted to the European Medicines Agency to support indication expansion of the EU label following triple combination approval- BOSTON
- Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) compared to placebo through 24 weeks of treatment - - ORKAMBI was well tolerated with safety data that were similar to data from previous Phase 3 open-label safety study -
-Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) through 8 weeks of tezacaftor/ivacaftor treatment- -Tezacaftor in combination with ivacaftor was generally well tolerated and safety data were consistent with previous
Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy
- Data showed 74% of people had undetectable hepatitis C virus 24 weeks after starting INCIVEK combination treatment - - Vertex to initiate Phase 3 study to evaluate 24- and 48-week treatment durations in people who are co-infected - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals
Phase III, 48-Week NEAT Study Results Comparing LEXIVA(TM) to Nelfinavir Published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS) Cambridge, MA and Research Triangle Park, NC, January 20, 2004 -- The final 48-week results from the NEAT trial, an open-label, multi-center study
- Relative mean improvement in lung function of approximately 17% from baseline compared to placebo achieved by people treated with VX-770; mean absolute improvement from baseline of approximately 10.5% compared to placebo; both measures through 24 and 48 weeks - - Significant improvements in all
-Mean relative improvement in lung function of 17.4% and mean absolute improvement of 12.5% from baseline compared to placebo in children treated with VX-770- - No discontinuations due to adverse events through 24 weeks - -Vertex on track to submit regulatory applications for the approval of VX-770
- Additional presentations at the North American CF Conference include data from PERSIST that showed sustained safety and efficacy of KALYDECO through 60 weeks of treatment among adolescents and adults treated in the Phase 3 STRIVE study - ANAHEIM, Calif.
