FDA Approves Pfizer's Revatio as Treatment for Pulmonary Arterial Hypertension

Pfizer has received FDA approval for Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension (PAH).

Sildenafil citrate is the active ingredient in Viagra, Pfizer's blockbuster erectile dysfunction drug.

The FDA approval was based on results of a large randomized, double-blind, placebo-controlled study involving 277 patients with PAH, an aggressive and life-shortening vascular disease. The study measured the exercise capability of patients after 12 weeks of treatment. Patients were randomized to receive 20 mg, 40 mg, or 80 mg of Revatio or a placebo three times a day.

All three Revatio treatment groups showed highly significant improvements in the six-minute walk distance, the standard measure of efficacy in PAH trials, compared to patients who received placebo. No differences were observed among the Revatio doses studied, therefore, the approved dosage is limited to 20 mg three times daily.

Pfizer said it expects Revatio to be available in retail pharmacies in mid-July.