The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of of GSK and Theravance’s Breo Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of COPD. The PADAC meeting had been rescheduled from an earlier date due to weather.
During the rescheduled meeting on April 17, the committee voted in favor of approval of Breo Ellipta for maintenance treatment of COPD and for reduction of exacerbations. Both votes were recorded as 9 to 4 in favor of approval; however, the actual vote was apparently 8 to 5 in both cases, with an incorrect result read into the official record and therefore unchangeable.
GSK President of Pharmaceuticals, R&D, Patrick Vallance commented, “We are pleased with the outcome of today’s meeting. COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients’ lives. This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year.”
Theravance CEO Rick E. Winningham added, “After a decade of development in this program, our collaboration with GSK is one step closer to providing an important therapeutic option to COPD patients. We are proud to collaborate with GSK on the development and potential commercialization of treatments for COPD and other respiratory diseases. The panel’s positive recommendation of Breo Ellipta represents an important achievement in a transformative year for Theravance.”
The PDUFA date for the products is May 12, 2013. GSK and Theravance say that they are also considering filing an NDA for Breo Ellipta for the treatment of asthma.
Read the GSK/Theravance press release.
