GSK, Theravance gets approval for COPD drug Anoro in Europe

The drug is a combination of umeclidinium(UMEC), a long-acting muscarinic antagonist (LAMA) that helps lung function, and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta.

The company said that the licensed strength of UMEC/VI in Europe is 55mcg / 22mcg.

GSK SVP and head of Global Respiratory Franchise Darrell Baker said there are many people across Europe living with COPD who experience a variety of symptoms and for whom the disease represents a significant burden.

"GSK is committed to developing a range of new therapeutic options that provide physicians with treatment choices when considering individual patient needs," Baker said.

"We are delighted by today’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."

Theravance chief executive officer Rick Winningham said the company is happy 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.

AS part of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15m following marketing authorization for UMEC/VI by the EC and a further $15m will be paid to GSK following the launch of the product in Europe.

Initial launch of the product is expected to take place in Europe in second-third quarter of 2014 with additional launches to follow thereafter.