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Ivacaftor / lumacaftor News

Kalydeco Approval Widened for More Types of Cystic Fibrosis

Posted 18 May 2017 by Drugs.com

THURSDAY, May 18, 2017 – The U.S. Food and Drug Administration says it has expanded approval for the cystic fibrosis drug Kalydeco (ivacaftor) to include 33 mutations of the disease, up from the previous 10 mutations. In a media release, the agency said its decision was based on results of laboratory testing and previous clinical trials. "Many rare cystic fibrosis mutations have such small ...

FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation

Posted 29 Sep 2016 by Drugs.com

BOSTON--(BUSINESS WIRE) September 28, 2016 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Orkambi (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest population of those with CF, a rare, ...

Cystic Fibrosis Drug Seems OK for Preschoolers: Study

Posted 25 Jan 2016 by Drugs.com

MONDAY, Jan. 25, 2016 – The cystic fibrosis drug ivacaftor appears safe and effective for young children, a drug company-funded study suggests. "This was a small trial, but we are thrilled to see these results," said study leader Jane Davies, from the National Heart and Lung Institute at Imperial College London in England. "Ivacaftor is a potential new treatment to offer children aged 2 years ...

Finding Disease Cures Can Take Up to a Century: Analysis

Posted 24 Sep 2015 by Drugs.com

THURSDAY, Sept. 24, 2015 – A team of scientists has looked back over decades of discovery to conclude that it can take dozens of years, even a century, for cumulative research to lead to a cure for a single disease. The finding is disheartening given the current U.S. government underfunding of the basic science needed to investigate diseases, said a team led by Dr. R. Sanders Williams, president ...

Orkambi Approved for Cystic Fibrosis

Posted 2 Jul 2015 by Drugs.com

THURSDAY, July 2, 2015 – Orkambi (lumacaftor and ivacaftor) has been approved by the U.S. Food and Drug Administration to treat cystic fibrosis in patients who have inherited two copies of a specific gene mutation from their parents. The F508del mutation causes production of an abnormal protein that disrupts transport of water and chloride through the body, the FDA said Thursday in a news ...

FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis

Posted 2 Jul 2015 by Drugs.com

July 2, 2015 – The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation. Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an ...

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Further Information

Related Condition Support Groups

Cystic Fibrosis

Related Drug Support Groups

Orkambi

Ivacaftor / lumacaftor Patient Information at Drugs.com