GlaxoSmithKline 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 authorization 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.
Patrick Vallance, GSK’s president of pharmaceuticals R&D, said: “COPD affects millions of people across Europe and GSK is committed to developing new therapeutic options that could help these patients. Today’s positive opinion is a step towards us making this important new medicine available. We are looking forward to the final decision of the European Commission in the near future.”
“We are pleased with the positive opinion which brings UMEC/VI closer to approval in Europe,” said Rick Winningham, chief executive officer of Theravance. “This is an important milestone and reflects the ongoing efforts of the collaboration between Theravance and GSK to research and develop new respiratory medicines that meet patient needs.”
A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission. A final decision by the European Commission is anticipated during the second quarter of 2014.
The Phase 3 pivotal program for UMEC/VI included seven clinical studies with almost 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 U.S. Food and Drug Administration (FDA) and Health Canada. In Europe, the UMEC/VI strength of 55mcg/22mcg is specified as the delivered dose (emitted from the inhaler) which is equivalent to the 62.5mcg/25mcg pre-dispensed dose (contained inside the inhaler) approved in the United States and Canada.
In April 2013, a regulatory submission for UMEC/VI under the trade name Anoro Ellipta was filed in Japan and is currently under review.
UMEC/VI is an investigational medicine and is not currently approved anywhere in the world outside of the United States and Canada.
Date: February 20, 2014
Source: GSK
Filed Under: Drug Discovery
