Anoro Gets Positive CHMP Opinion For COPD Treatment - Quick Facts

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance, Inc. (THRX) reported that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol or 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 or COPD.

Anoro is a combination of UMEC, a long-acting muscarinic antagonist and VI, a long-acting beta2 agonist in a single inhaler, the Ellipta. The proposed strength is UMEC/VI 55mcg / 22 mcg.

Theravance said it is pleased with the positive opinion which brings UMEC/VI closer to approval in Europe. A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, while a final decision by the Commission is anticipated in the second quarter of 2014.

The phase III pivotal programme for UMEC/VI comprised 7 clinical studies with nearly 6,000 patients with COPD. In December 2013, Anoro Ellipta 62.5mcg / 25mcg was approved for use in appropriate patients with COPD by both the US Food and Drug Administration and Health Canada.