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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Approves GSK’s Anoro Ellipta for COPD

Dec. 20, 2013
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The FDA on Wednesday approved GlaxoSmithKline’s Anoro Ellipta, an inhaler-based treatment for chronic obstructive pulmonary disease (COPD).

The approval advances the first-ever once-daily dual bronchodilator to be approved for COPD in in the U.S., according to GSK. The approval follows a positive Sept. 10 advisory committee recommendation and is based on seven Phase III clinical trials involving 6,000 COPD patients.

In announcing the approval, FDA officials lauded the drug as an alternative treatment for a
disease that is the third leading cause of death in the U.S.

The drug carries a boxed warning of increased asthma-related death. GSK has submitted Anoro Ellipta for approval in the EU, Japan, Brazil and elsewhere. — Lena Freund

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