GlaxoSmithKline plc (GSK) has submitted a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD).
UMEC is an investigational bronchodilator molecule (formerly known as GSK573719), a long-acting muscarinic antagonist (LAMA), administered using the ELLIPTA inhaler.
A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Regulatory filings for UMEC monotherapy are imminent in the US and planned in other countries during the course of 2013.
UMEC monotherapy is one of several late-stage assets in the GSK respiratory development portfolio. The development portfolio includes umeclidinium /vilanterol (UMEC/VI, with proposed brand name ANORO), fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR and BREO), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.ANORO, RELVAR, BREO and ELLIPTA are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by any regulatory authorities.