GlaxoSmithKline and partner Theravance are celebrating after the European Commission granted marketing authorisation for their chronic obstructive pulmonary disease Anoro.
Anoro is a once-daily treatment combining umeclidinium, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting beta agonist (LABA), delivered by GSK’s Ellipta inhaler. The combo was approved in the USA with a boxed warning in December 2013.
The approval included a review of eight Phase III trials which included over 6,000 COPD patients, with 1,296 treated with Anoro. The green light in Europe has triggered a $15 million milestone payment to GSK from Theravance and a further $15 million once the first launches of Anoro take place in Q2-Q3.
GSK has very high hopes for Anoro, especially as its biggest earner, the COPD and asthma drug Advair (salmeterol/fluticasone) is now facing generic competition.
