Tag Archives: Orkambi

August, 2018

9 August
FDA Approves Vertex’s Orkambi to Treat Cystic Fibrosis Patients Ages 2-5 Years with Most Common Form of Disease

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF …
Share

28 October
Vertex’s Orkambi and Kalydeco Show the Potential to Modify the Progression of Cystic Fibrosis

ORLANDO, Fla.–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the presentation of long-term data demonstrating that ORKAMBI® (lumacaftor/ivacaftor) and KALYDECO® (ivacaftor) show the potential to modify the progression of cystic fibrosis (CF). The presentations given at the 30th Annual North American Cystic Fibrosis Conference (NACFC) include final data from the …
Share

12 May
FDA Panel Recommends Approval of Vertex’s Cystic Fibrosis Combo

A US Food and Drug Administration (FDA) advisory committee has recommended approval of Vertex Pharmaceuticals’ new combination therapy for treatment of cystic fibrosis (CF). The agency’s Pulmonary-Allergy Drugs Advisory Committee voted 12 to 1 in favor of approving the drug, which consists of Vertex’s already approved drug Kalydeco (ivacaftor) and …
Share
8 May
FDA Staff Questions Benefit of Vertex’s Combo Cystic Fibrosis Drug

US health regulators released briefing documents Friday morning questioning the benefit of Vertex Pharmaceuticals’ combination therapy for cystic fibrosis patients. Ahead of an advisory panel review, scheduled for Tuesday, May 12, US Food and Drug Administration (FDA) staff reviewers questioned one of the two drugs in the combination cystic fibrosis …
Share