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Surya Bhatt, MD, MSPH, is coprincipal investigator for the 2 pivotal phase 3 clinical trials that supported today's landmark FDA approval of dupilumab for COPD.
Dupilumab represents the first new treatment approach for uncontrolled COPD in more than a decade and reduced disease exacerbations by 34% in clinical trials.
In a large study of patients with COPD, a small increase in 5-year all-cause mortality risk was observed among those using roflumilast.
ICYMI: A quick look at 7 key drugs FDA-approved in the second quarter for conditions commonly seen in primary care.
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The dual interleukin-4, 13 inhibitor reduced COPD exacerbation rates by as much as 34% for individuals with COPD with type 2 inflammation, Bhatt explains.
FDA has no concerns about the "approvability" of dupilumab for the new indication but needs additional time to review phase 3 data it requested early in May.
Your daily dose of the clinical news you may have missed.
Adults with undiagnosed asthma or COPD who were randomly detected and assigned to specialist or usual care all had improved outcomes at 1 year, Canadian authors reported.