The Food and Drug Administration has officially approved Breo Ellipta, a much-anticipated new treatment for chronic obstructive pulmonary disease. The inhaled drug was developed by GlaxoSmithKline and Theravance, and is touted as the first once-daily maintenance treatment for COPD.
An FDA panel recommended approval in April, and the agency acted quickly, granting approval last Friday.
Breo Ellipta reduces lung inflammation and helps relax airway muscles. It is approved to reduce exacerbations among COPD patients with a history of exacerbations. Trials have indicated that Breo Ellipta may cause fewer serious side effects than other COPD drugs.
“The FDA approval of Breo Ellipta brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States,” said Rick E. Winningham, CEO of Theravance. “After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK.”
Some analysts predict Breo Ellipta could result in as much as $4 billion annually for the two pharmaceutical companies behind it. The treatment is expected to be available by the third quarter of 2013.
Under the terms of the 2002 LABA collaboration agreement, Theravance is now obligated to make a payment of $30 million to GSK.
