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GSK seeks EU approval for umeclidinium monotherapy for COPD patients

GlaxoSmithKline (GSK) has submitted Marketing Authorisation Application (MAA) in the European Union for 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), that is administered using the ELLIPTA inhaler.

The MAA for UMEC monotherapy has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

UMEC monotherapy is one of the late-stage assets in the GSK respiratory development portfolio, which include umeclidinium /vilanterol, fluticasone furoate/vilanterol, VI monotherapy and MABA developed in collaboration with Theravance, in addition to GSK’s medicines FF monotherapy and anti-IL5 MAb.