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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