MYOG Myogen announces positive top line results for pivotal Phase 3 trial of ambrisentan (35.82 )
Co announces positive top line results of the ARIES-1 trial, the second pivotal Phase 3 trial evaluating ambrisentan, an oral endothelin receptor antagonist, in pulmonary arterial hypertension. The trial met the primary efficacy endpoint of improved exercise capacity for both ambrisentan dose groups, with an excellent safety profile and no observed liver function abnormalities in the ambrisentan treatment groups. Co expects to submit the ambrisentan N.D.A. to the FDA in Q4.
MYOG reports positive Phase III results for Ambrisentan
Myogen, Inc. announced positive top line results of the ARIES-1 trial, the second pivotal Phase 3 trial evaluating ambrisentan, an oral endothelin receptor antagonist, in pulmonary arterial hypertension. The trial met the primary efficacy endpoint of improved exercise capacity for both ambrisentan dose groups, with an excellent safety profile and no observed liver function abnormalities in the ambrisentan treatment groups. On the basis of the results of ARIES-1 & -2, Myogen expects to submit the ambrisentan New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2006. :