- Both trials met the primary and key secondary endpoints at the pre-specified interim analysis - - Data continue to demonstrate transformative and durable benefit - - Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant - BOSTON & ZUG,
- 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
