Myogen pulmonary blood pressure treatment gets fast tracked

Fast track programs are 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. Such a designation means the FDA will review a potential new drug in approximately six months rather than taking the usual 10 or 12 months to complete the process.

Pulmonary arterial hypertension (PAH) is a life-threatening, progressive, and incurable disease of the pulmonary vasculature. It results in dangerously high blood pressure in the arteries near the lungs. Myogen is currently investigating the effects of ambrisentan for this indication in phase III clinical studies. Previous research suggests the drug may delay the clinical worsening of PAH.

“Based on clinical trial results to date and the properties of ambrisentan, Myogen believes that, if ambrisentan is ultimately approved, it may offer significant clinical benefit to PAH patients,” said Dr Michael Gerber, senior vice president of clinical development and regulatory affairs for Myogen.

Ambrisentan is a non-sulfonamide, propanoic acid-class, type-A selective endothelin receptor antagonist. Endothelin is a small peptide hormone that plays a critical role in the control of blood flow and cell growth. Myogen believes that agents that block the detrimental effects of endothelin may provide significant benefits in the treatment of these conditions.

Myogen has licensed ambrisentan ex-US rights to GlaxoSmithKline. The drug has been granted orphan drug designation for the treatment of PAH in both the US and in European.