-KALYDECO is the first medicine to treat the underlying cause of CF for people with specific mutations in the CFTR gene- -KALYDECO facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein- -The eight additional mutations are present in
--Approximately 500 people with cystic fibrosis ages 6 and older have the R117H mutation in the United States -- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug
-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the
-Approximately 2,400 children ages 6 to 11 have two copies of the F508del mutation in the U.S. - -Target review date of September 30, 2016 set for the FDA's decision on the application- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the U.S.
-Mean absolute improvement in ppFEV 1 of 14.0 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation compared to placebo (p
-Mean absolute improvement in ppFEV 1 of 13.8 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation (F/MF) compared to placebo (p
- Study in people who have two copies of the F508del mutation demonstrated a mean absolute improvement in ppFEV 1 of 4.0 percentage points compared to placebo (p
-Combination of lumacaftor and ivacaftor is the first regimen designed to treat the underlying cause of CF in people with two copies of the F508del mutation, the most common form of the disease- -All four 24-week treatment arms achieved primary endpoint of mean absolute improvement in FEV 1
-Treatment with combination of VX-661 and ivacaftor for 28 days in two highest dose groups resulted in mean relative increases in lung function (percent predicted FEV 1 ) of 9.0% (p=0.01) and 7.5% (p=0.02) versus placebo - -VX-661 was generally well-tolerated alone and in combination with
- Advisory Committee for the Food and Drug Administration reviewing the telaprevir New Drug Application for the treatment of hepatitis C- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) announced that NASDAQ today halted trading of the company's common stock.
