CHMP recommends Anoro Ellipta for COPD - GSK
GlaxoSmithKline plc and Theravance, Inc. announced that the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol (UMEC/VI) under the proposed brand name Anoro as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Anoro is a combination of UMEC, a long-acting muscarinic antagonist (LAMA) and VI, a long-acting beta2 agonist (LABA) in a single inhaler, the Ellipta. The proposed strength is UMEC/VI 55mcg / 22 mcg. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
The drug, in a different strength formulation, was approved by regulators in the United States and Canada in December 2013.
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