The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK’s Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The committee voted 10-3 in agreement that the safety of the UMEC/VI inhaler has been demonstrated and 13-0 on the question of efficacy. GSK submitted the NDA for Anoro Ellipta in December 2012.
GSK President of Pharmaceuticals R&D Patrick Vallance commented, “Today’s recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD – a disease that affects millions of Americans. If approved, Anoro Ellipta will be the first once-daily dual bronchodilator available in the US, marking another significant milestone for GSK’s portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review.”
Theravance CEO Rick E Winningham added, “We are pleased with the Advisory Committee’s support of UMEC/VI. This is a transformative year for Theravance and today’s positive recommendation brings the second major respiratory medicine in our GSK collaboration closer to approval and becoming an important therapeutic option for COPD patients.”
The FDA set a PDUFA date of December 18, 2013 for the UMEC/VI application. GSK and Theravance have also submitted applications for the product in Europe and in Japan.
Read the GSK and Theravance press release.
