The trial met the primary efficacy endpoint of improved exercise capacity for both ambrisentan dose groups, with a good safety profile and no observed liver function abnormalities in the ambrisentan treatment groups.
On the basis of the results of the two pivotal trials, Myogen expects to submit a new drug application to the FDA for ambrisentan in the fourth quarter of 2006.
Results of the trial demonstrated that with once-daily dosing, 10 mg of ambrisentan improved the placebo-corrected mean six-minute walk distance (6MWD) by 51.4 meters and 5 mg of ambrisentan improved the placebo-corrected mean 6MWD by 30.6 meters, indicating improved exercise capacity.
These results trigger a $5.25 million milestone payment under Myogen’s ambrisentan sublicense agreement with GlaxoSmithKline.
“With two positive, well-controlled studies demonstrating robust efficacy and a safety database of more than 400 patients on long-term treatment, we have the foundation for high quality regulatory submissions worldwide,” said Dr Michael Gerber, senior vice president of clinical development and regulatory affairs for Myogen.