GSK’s Anoro Ellipta Needs CV Postmarket Study, FDA Panel Says In Endorsement

Pulmonary-Allergy Drugs Advisory Committee votes in favor of what could become the first-approved LAMA/LABA combo for COPD but wants postmarket safety study in patients with more severe cardiovascular disease.

FDA advisors voted 11-2 in favor of approval of GlaxoSmithKline PLC’s Anoro Ellipta for chronic obstructive pulmonary disease Sept. 10, but said the novel combination treatment needs a post-market requirement to better characterize cardiac safety concerns in patients who are more severely ill than those evaluated in clinical trials.

Despite favoring the drug’s approval, many members of the Pulmonary-Allergy Drugs Advisory Committee also said the drug should come with...