Theravance has announced that the the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee will meet jointly on March 19, 2015 to discuss whether the Breo Ellipta fluticasone/vilanterol DPI should be approved for the treatment of asthma in patients 12 and older. Theravance and GSK filed sNDA 204275-S001 in June 2014.
According to the announcement of the meeting in the Federal Register, “The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended.”
Breo Ellipta has been approved in the US for the treatment of COPD since May 2013. In Europe, where the inhaler is marketed as Relvar Ellipta, the product is approved for the treatment of both COPD and asthma for certain patients.
Read the Theravance press release.
Read the Federal Register announcement.
View the FDA information page for the meeting.
