GlaxoSmithKline (GSK) and Theravance have announced the European Commission’s marketing approval for Anoro (umeclidinium/vilanterol) for the treatment of chronic obstructive pulmonary disease (COPD).
The European Commission has approved Anoro as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Anoro comprises umeclidinium (UMEC) and vilanterol (VI) in a single inhaler Ellipta. Umeclidinium is a long-acting muscarinic antagonist, while vilanterol is a long-acting beta2 agonist.
The licensed strength in Europe is UMEC/VI 55mcg / 22mcg.
Assessment of UMEC/VI by the European Medicines Agency included a review of eight Phase III clinical studies in more than 6,000 COPD patients. Within this, 1,296 patients received the recommended dose of UMEC/VI 55/22mcg once-daily.
GSK Global Respiratory Franchise senior vice president and head Darrell Baker said that the company is delighted by the European Commission’s marketing authorisation for Anoro Ellipta, which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate.
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Theravance CEO Rick Winningham said that the company is very pleased that Anoro Ellipta is now licensed across 31 European countries for the treatment of COPD.
"We believe this will be an important treatment option for appropriate patients with COPD and is a further positive outcome from the collaboration between Theravance and GSK to bring to market new respiratory medicines that meet patient needs," Winningham said.
Pursuant to the terms of the 2002 long-acting beta2 agonist collaboration agreement, GSK will receive milestone payment of $15m from Theravance following the marketing authorisation for UMEC/VI by the European Commission. Theravance will also pay $15m to GSK after the European launch of UMEC/VI.
First launch of Anoro in Europe is expected to begin in the second or third quarter of 2014 with additional launches to follow afterwards.
Image: A chest X-ray demonstrating severe chronic obstructive pulmonary disease. Photo: courtesy of Jmh649.