The FDA has announced the approval of GSK and Theravance’s Anoro Ellipta umeclidinium/vilanterol inhalation powder for the treatment of COPD. The approval triggers a $30 million milestone payment from Theravance to GSK. Theravance will pay another $30 million on launch, which is expected to take place in the first quarter of 2014.
GSK and Theravance submitted an NDA for the product in December 2012, and the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted for approval in September 2013.
The FDA Director of the Office of Drug Evaluation II, Curtis Rosebraugh, commented, “Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD. The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”
GSK Senior VP & Head, Global Respiratory Franchise, Darrell Baker said, “We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK.”
Theravance CEO Rick E Winningham added, “We are very pleased that Anoro Ellipta has become the first once-daily dual bronchodilator approved in the US for the treatment of COPD. This is a significant milestone for Theravance and GSK and is testament to our ongoing partnership and shared commitment to the development of respiratory medicines.”
Read the FDA press release.
Read the GSK/Theravance press release.
