FDA approves Pfizer’s Revatio for pulmonary arterial hypertension

The FDA approval was based on results of a large randomized, double-blind, placebo-controlled study involving 277 patients with pulmonary arterial hypertension (PAH). The study measured the exercise capability of patients after 12 weeks of treatment. Patients were randomized to receive Revatio 20mg, 40mg, or 80mg three times a day or placebo.

All three 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 20mg three times daily.

Patients taking Revatio also showed improvements in mean pulmonary artery pressure and other measures of cardiac function. A long-term non-placebo controlled extension trial was also conducted. At the end of one year, walk distance and functional class were stable and 94% of patients were still alive.

“Pfizer undertook a six-year clinical development program in PAH because patients with this devastating disease needed more medical options, and there was evidence that sildenafil could be an effective treatment,” said Dr Joe Feczko, Pfizer’s chief medical officer. “Revatio demonstrates our commitment to developing treatments for unmet medical needs, including rare conditions such as PAH, regardless of commercial potential.”