Thursday, March 09, 2006

More Good News for Myogen

The FDA has granted Fast Track status for Myogen's ambrisentan, currently in Phase III clinical trials. This designation is aimed to expedite the review process.

The FDA designated ambrisentan as a Fast Track product for the following reasons:

1. Ambrisentan is intended to treat PAH, a life-threatening, progressive, and
incurable disease of the pulmonary vasculature.
2. The ambrisentan development program has been designed to address the unmet medical needs of patients with PAH, by demonstrating the following:

a. Ambrisentan has the potential for improved effects on exercise capacity, an efficacy measure that has been shown to correlate with and be prognostic of long-term survival.
b. Ambrisentan appears to delay the clinical worsening of PAH, a progressive and ultimately fatal disease.

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