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New drug for cystic fibrosis : Regulatory approval, clinical uncertainty? Therapeutics Initiative (University of British Columbia)

Description

Therapeutics Letter 116 examines a new drug therapy for cystic fibrosis (CF). Conclusions: Lumacaftor/ivacaftor (Orkambi) is a new combination drug for the treatment of CF. Health Canada granted regulatory approval for this drug combination based on two 24-week placebo-controlled studies showing a 3% improvement with the drug in a lung function test (ppFEV1). There is insufficient evidence at the present time that lumacaftor/ivacaftor improves quality of life, morbidity or mortality in patients with cystic fibrosis.

Item Metadata

Title
New drug for cystic fibrosis : Regulatory approval, clinical uncertainty?
Alternate Title
Therapeutics Letter 116
Creator
Therapeutics Initiative (University of British Columbia)
Date Issued
2018-12
Description
Therapeutics Letter 116 examines a new drug therapy for cystic fibrosis (CF). Conclusions: Lumacaftor/ivacaftor (Orkambi) is a new combination drug for the treatment of CF. Health Canada granted regulatory approval for this drug combination based on two 24-week placebo-controlled studies showing a 3% improvement with the drug in a lung function test (ppFEV1). There is insufficient evidence at the present time that lumacaftor/ivacaftor improves quality of life, morbidity or mortality in patients with cystic fibrosis.
Subject
Cystic Fibrosis; Drug Combinations; Morbidity; Quality of Life
Genre
Other
Type
Text
Language
eng
Notes
The UBC TI is funded by the BC Ministry of Health to provide evidence-based information about drug therapy. We neither formulate nor adjudicate provincial drug policies.
Date Available
2023-06-20
Provider
Vancouver : University of British Columbia Library
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
DOI
10.14288/1.0433695
URI
http://hdl.handle.net/2429/85105
Affiliation
Medicine, Faculty of; Anesthesiology, Pharmacology and Therapeutics, Department of
Peer Review Status
Reviewed
Scholarly Level
Faculty; Researcher
Rights URI
http://creativecommons.org/licenses/by-nc-nd/4.0/
Aggregated Source Repository
DSpace

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Attribution-NonCommercial-NoDerivatives 4.0 International