LONDON (Reuters) - GlaxoSmithKline and Theravance’s new inhaled lung drug Relvar has been recommended for approval in Europe, Britain’s biggest drugmaker said on Thursday.
The green light from the European Medicines Agency follows approval for the product in May in the United States, where it is known as Breo. The medicine is inhaled through a palm-sized device called Ellipta.
The drug consists of a corticosteroid to reduce inflammation and a novel long-acting beta-agonist (LABA), which is designed to open the airways. While the U.S. approval so far only covers the treatment of chronic obstructive pulmonary disease (COPD), the European recommendation is for both asthma and COPD.
Patrick Vallance, GSK’s president of pharmaceuticals R&D, said the European regulator’s endorsement of the product for asthma was “particularly exciting”.
Relvar is one of two new medicines that GSK is relying on to reinvigorate its respiratory business as the company’s $8 billion-a-year blockbuster Advair faces the threat of generic competition in the years ahead.
The other key new lung drug is Anoro, which combines a LABA therapy with a long-acting muscarinic receptor antagonist (LAMA). It was recommended for approval by a U.S. federal advisory panel last week.
A final approval decision on Relvar by the European Commission is anticipated during the fourth quarter of 2013, GSK said. The Commission nearly always endorses the opinions of the medicines agency.
Reporting by Ben Hirschler; editing by David Evans