FiercePharma

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' ($VRTX) orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients ...
Nasdaq

Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages of 6 Months and 18 Years With the ...

- KALYDECO® (ivacaftor) is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function ...
Healio

FDA approves Kalydeco for patients with specific cystic fibrosis mutation

Please provide your email address to receive an email when new articles are posted on . Vertex Pharmaceuticals has received FDA approval for ivacaftor to treat cystic fibrosis among patients, aged 6 ...
FierceBiotech

Vertex's Kalydeco flunks a Phase III for cystic fibrosis

Vertex Pharmaceuticals' ($VRTX) piecemeal approach to the world's cystic fibrosis sufferers took a hit as Kalydeco failed to meet its primary endpoint in a Phase III ...
FiercePharma

FDA Advisory Committee Recommends Approval of KALYDECO® (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration's Pulmonary Allergy Drugs Advisory Committee (PADAC) voted 13-2 ...
Wall Street Journal

Vertex's Kalydeco Misses Cystic-Fibrosis Study Goal

Vertex Pharmaceuticals Inc. said that its cystic-fibrosis drug Kalydeco failed to show a statistically significant benefit during a late-stage study, casting uncertainty over whether the treatment ...
FierceBiotech

Vertex Announces Results of Phase 3 Study of Ivacaftor in People with CF who have the R117H Mutation

Michael Partridge, 617-341-6108orKelly Lewis, 617-961-7530orNorth America:Zach Barber, 617-341-6470orEurope:Megan Goulart, +41 22 593 6066 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today ...
PharmaTimes

EU expands reach of Vertex’ CF drug Kalydeco

Kalydeco is the only approved medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation EU regulators have expanded the treatment scope of Vertex’ ...
Yahoo Finance

Vertex Pharmaceuticals' Kalydeco Wins FDA Panel Backing

Vertex Pharma is looking to get Kalydeco approved for the treatment of patients (six years of age and above) with CF who have the R117H mutation in the cystic fibrosis transmembrane regulatory (:CFTR) ...
Nasdaq

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages 6 Months and 18 Years With the ...

- If approved, KALYDECO® (ivacaftor) will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual ...
Business Wire

Vertex Announces Results of Phase 3 Study of Ivacaftor in People with CF who have the R117H Mutation

-Mean absolute treatment difference in lung function across all patients was 2.1 percentage points (p=0.20) and mean relative treatment difference was 5.0% (p=0.06)(n=69); study did not meet its ...