GSK's COPD Drug Anoro Receives Positive Opinion From CHMP
GlaxoSmithKline together with partner Theravance announced that its chronic obstructive pulmonary disease (COPD) treatment Anoro has received positive opinion and recommendation for marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Anoro is the proposed name of GSK’s umeclidinium/vilanterol (UMEC/VI) used as a once-daily, maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease. The drug is a combination of long-acting muscarinic antagonist (LAMA), UMEC, and long-acting beta2 agonist (LABA) VI in Ellipta, a single inhaler. GSK proposed dosage strength of UMEC/VI 55mcg / 22 mc.
The company said the proposed UMEC/VI strength of 55mcg / 22mcg in Europe is determined as the delivered dose expelled from the inhaler equal to the 62.5mcg / 25mcg pre-dispensed dose (contained inside the inhaler) approved in the U.S. and Canada.
GSK’s president of pharmaceuticals R&D Patrick Vallance 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.”
Theravance chief executive officer Rick E. Winningham said, “We are pleased with the positive opinion which brings UMEC/VI closer to approval in Europe. 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.”
The U.S. Food and Drug Administration (FDA) and Health Canada granted approval for Anoro™ Ellipta™ 62.5mcg / 25mcg last December 2013. The approvals were based on phase III pivotal program for UMEC/VI which included seven clinical studies and involved nearly 6,000 patients with COPD.
The company stated the CHMP positive opinion is one of the final steps required before the European Commission grants marketing authorization, which is expected during the second quarter of 2014.