Gilead's ambrisentan NDA accepted by FDA

USA-based biopharmaceutical company Gilead Sciences says that the Food and Drug Administration has accepted its New Drug Application for the pulmonary arterial hypertension treatment ambrisentan. Furthermore, the company said that the agency has earmarked the drug for priority review with a target completion date of June 18.

The California-headquartered firm explained that the drug, which is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type A receptor, reduces the amount of vasoconstriction and cell proliferation that is associated with elevated ETA levels in PAH.

Analysts at Lehman Brothers said that the FDA's decision was broadly in line with its expectations for a mid-2007 product launch, and that they had not revised its valuation.