Ambrisentan receives FDA Fast Track designation for PAH development
The US Food and Drug Administration (FDA) has granted Fast Track designation to Colorado-based Myogen's ambrisentan.
The US Food and Drug Administration (FDA) has granted Fast Track designation to Colorado-based Myogen's ambrisentan.
A type-A selective endothelin receptor antagonist (ERA) under development as a once-daily oral therapy for patients with pulmonary arterial hypertension (PAH), ambrisentan is currently in Phase III development and has been granted orphan drug designation for the treatment of PAH in both the US and EU.
The FDA's fast track programme is designed to "facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs".
Ambrisentan qualified for the programme as PAH is adjudged to be "a life-threatening, progressive, and incurable disease"; and the ambrisentan development programme is adjudged to have been "designed to address the unmet medical needs of patients with PAH by demonstrating [ambrisentan's] potential for improved effects on exercise capacity - an efficacy measure that has been shown to correlate with and be prognostic of long-term survival - [and] appear[ing] to delay the clinical worsening of PAH."
Myogen recently signed a PAH collaboration with GlaxoSmithKline (GSK) (London, UK) which gave GSK commercialisation rights for ambrisentan in all territories outside the US. Top-line results from the ARIES-1 trial of ambrisentan are expected in April 2006.