Glaxo pulmonary drug label and dose expansion trial yields positive results

In a 12-week late stage trial, Glaxo's (GSK -1%) Incruse Ellipta (umeclidinium) achieved its primary endpoint of a statistically significant improvement in lung function when compared to placebo as measured by trough FEV1 at day 85 in patients with chronic obstructive pulmonary disease.

The study evaluated the safety and efficacy of umeclidinium (UMEC) in two doses (62.5 mcg and 125 mcg) in combination with Advair Diskus (fluticasone proprionate and salmeterol).

Both doses in combination with Advair Diskus also demonstrated statistically significant improvements in secondary efficacy endpoints of 0-6 hour weighted mean FEV1 at day 84 and mean number of puffs of rescue medicine per day (weeks 1-12) compared to placebo plus Advair Diskus.

Umeclidinium 62.5 mcg is currently approved in the U.S., Canada and Europe. The 125 mcg dose is not cleared for sale anywhere in the world.

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