Safety Meta-Analysis Trumped By Long, Large Trial At Spiriva Advisory Panel
A clinical trial trumps a meta-analysis for assessing drug safety, at least when it's large and well-done - that was the message from FDA's Pulmonary-Allergy Drugs Advisory Committee during its review of an additional indication for Boehringer Ingelheim's Spiriva HandiHaler Nov. 19
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FDA Pulmonary-Allergy Drugs Advisory Committee to review NDA for COPD and will discuss safety results from trial comparing inhalation spray to powder.
Boehringer Ingelheim’s long acting beta-adrenergic agonist for chronic obstructive pulmonary disease will have to overcome LABA class issues in asthma at an advisory committee in January. The drug is up first for single-agent approval, but it is meant to be half of a combination therapy with the blockbuster treatment Spiriva.
Two years after an Early Communication about potential risk and two years months after an advisory gave it the thumbs ups, Boehringer Ingleheim's COPD therapy gets an official FDA announcement that it does not appear to be linked to increased CV events.