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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?
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Alternate Title |
Therapeutics Letter 116
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Creator | |
Date Issued |
2018-12
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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.
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Subject | |
Genre | |
Type | |
Language |
eng
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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.
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Date Available |
2023-06-20
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution-NonCommercial-NoDerivatives 4.0 International
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DOI |
10.14288/1.0433695
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URI | |
Affiliation | |
Peer Review Status |
Reviewed
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Scholarly Level |
Faculty; Researcher
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Rights URI | |
Aggregated Source Repository |
DSpace
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Item Citations and Data
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International