Just over a week after advisors to the US Food and Drug Administration gave the thumbs-up to Breo Ellipta, GlaxoSmithKline has announced the submission of another chronic obstructive pulmonary disease drug, umeclidinium bromide, in Europe.
Umeclidinium is an investigational long-acting muscarinic antagonist (LAMA), which is administered using the Ellipta inhaler. A marketing authorisation application has been submitted to the European Medicines Agency for the drug to be used as monotherapy to relieve symptoms in adults with COPD; a US filing is imminent, GSK says.
A fixed-dose inhaled dry powder formulation combination of umeclidinium and the long-acting beta-agonist (LABA) vilanterol is already under review under the proposed brand-name Anoro. The combo has been developed in collaboration with Theravance, though the monotherapy is GSK's responsibility.
Earlier this month, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted in favour of Breo Ellipta, which combines an inhaled corticosteroid (fluticasone) with the LABA vilanterol.
Theravance to split in two
Breo Ellipta is also being developed with Theravance which last week unveiled plans to split into two publicly-traded companies.
The first, Royalty Management Co, will deal with its late-stage, partnered respiratory assets with GSK, while the other, Theravance Biopharma, will seek to discover small-molecule medicines "in areas of significant unmet medical need". The latter's key project is the superbug antibiotic Vibativ (telavancin) for the treatment of nosocomial pneumonia.
Chief executive Rick Winningham said the firm was going for separation "following a review of alternatives to maximise the value of our portfolio". GSK owns over a quarter of Theravance and it had been rumoured that the UK drug giant was planning to buy the latter.