The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22 mcg UMEC/VI, delivered by the Ellipta DPI. Anoro Ellipta was approved in the US in December 2013 and in Canada in January 2014.
GSK President of Pharmaceuticals R&D Patrick Vallance commented, “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 CEO 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.”
Read the GSK/Theravance press release.
