GlaxoSmithKline's Lung Disease Drug Gets European Green Light
GlaxoSmithKline (NYSE:GSK) and Theravance (NASDAQ:THRX) said Thursday they have reached the final step toward European marketing approval for their experimental drug for chronic obstructive pulmonary disease, one of the most common forms of lung disease.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for umeclidinium/vilanterol under the proposed brand name Anoro.
A positive opinion by the committee typically follows marketing approval by the European Commission, and the drug companies said a final decision is expected during the second quarter.
The once-daily drug, a combination of umeclidinium/vilanterol and Ellipta, would be used to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
"COPD affects millions of people across Europe and GSK is committed to developing new therapeutic options that could help these patients,” Patrick Vallance, GSK's President of Pharmaceuticals R&D, said in a statement. “Today's positive opinion is a step towards us making this important new medicine available.”
In December, the U.S. Food and Drug Administration approved of GlaxoSmithKline’s Anoro Ellipta to treat airflow obstruction in patients with chronic obstructive pulmonary disease in the U.S.
Shares of GSK were up about 0.65% to $56.07 in early trade, while those of Theravance were down 1% to $39.92.