Pharmaceutical Business review

GSK seeks EU approval for umeclidinium monotherapy for COPD patients

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.