GlaxoSmithKline (GSK) is planning to launch its Anoro combination therapy for chronic obstructive pulmonary disorder (COPD) in the EU in the coming weeks following approval from the European Commission.
Anoro combines the long-acting muscarinic antagonist (LAMA) umeclidinium with long-acting beta agonist (LABA) vilanterol and was developed by GSK in collaboration with US company Theravance.
The new product became the first approved LAMA/LABA combination for COPD in the US last December and is tipped to become a blockbuster, with analysts predicting $1bn in sales within a couple of years of launch and peaking at a little under $3bn. It was launched in the US last week and is already available in pharmacies.
It is not the first LAMA/LABA to be approved in Europe, however, as that distinction went to Novartis’ rival product Ultibro (glycopyrronium and indacaterol) which was given the green light last September. Anoro has also been approved in Canada and is under regulatory review in Japan, while its umeclidinium monotherapy – called Incruse – has been approved both in Europe and the US.
The approval of Anoro by the EC follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February, which was backed by data from eight phase III trials involving more than 6,000 patients.
GSK needs its new respiratory products – which also include Theravance-partnered combination LABA and steroid drug Breo/Relvar (vilanterol and fluticasone) – if it is to lessen the impact of emerging competition to its $7bn-a-year blockbuster Advair/Seretide (salmeterol and fluticasone).
Breo has got off to a somewhat slow start in the market, although GSK is expecting this to pick up as insurance coverage grows in the US and it is also predicted to top $1bn in peak sales. Additional upside could come from approval in asthma; Theravance said recently GSK plans to file Breo for this indication later this year in the US.
Approval of Anoro in the EU sparks a $15m milestone payment from Theravance to GSK, with another $15m in the offing on the first European launch of the product.