Anoro Ellipta umeclidinium bromide/vilanterol: Phase III data
Top-line data from the double-blind, international Phase III 114951 trial in about 700 patients showed that once-daily 62.5/25 µg Anoro umeclidinium bromide/vilanterol administered via the Ellipta dry powder inhaler met the primary endpoint of improving weighted mean FEV1 over 0-24 hours from baseline to day 84 vs. twice-daily 250/50 µg Advair fluticasone propionate/salmeterol administered via the Diskus multi-dose powdered inhaler. Specifically, Anoro Ellipta improved the endpoint by 101 mL compared to Advair Diskus (p<0.001). The trial enrolled patients with a post-salbutamol FEV1 of >=30% and <=70% and no history of moderate to severe COPD exacerbations in the last 12 months.
In February, EMA's CHMP recommended approval of an MAA from GlaxoSmithKline for Anoro Ellipta as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults with COPD. CHMP also backed approval of the product under the name Laventair. The product is already approved in Canada and the U.S., where a launch is expected this quarter. The Canadian launch is slated for 2Q14 (see BioCentury, Feb. 24). GSK and Theravance are partnered under a 2002 deal to develop compounds to treat asthma and COPD, including Anoro Ellipta. ...