Tracleer and PPH News
FDA Approves Pfizer's Revatio As Treatment for Pulmonary Arterial Hypertension
Revatio has same active ingredient as Viagra
NEW YORK, June 6 /PRNewswire-FirstCall/ -- Pfizer Inc said today the U.S. Food and Drug Administration has approved Revatio(TM) (sildenafil citrate) as a treatment for pulmonary arterial hypertension (PAH), a rare, aggressive and life-shortening vascular disease. Sildenafil citrate is the active ingredient in Viagra®, Pfizer's erectile dysfunction medication used by more than 26 million men worldwide.
PAH is characterized by dangerously high pressure in the blood vessels that lead from the heart to the lungs. It is estimated to affect approximately 100,000 people worldwide. Symptoms include difficulty breathing, dizziness and fatigue. Left untreated, patients have an average survival time of less than three years from the time of diagnosis.
"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."
The FDA granted Revatio a priority review. The FDA approval was based on results of a large randomized, double-blind, placebo-controlled study involving 277 patients with PAH. The study measured the exercise capability of patients after 12 weeks of treatment. Patients were randomized to receive Revatio 20 mg, 40 mg, or 80 mg 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 20 mg 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 percent of patients were still alive.
Revatio is the first oral treatment for PAH to be approved for patients with an early stage of the disease, allowing physicians to treat patients earlier in this progressive disorder.
Revatio was generally well tolerated at all doses studied. The most common side effects were headache, dyspepsia, flushing, epistaxis, and insomnia.
The Revatio 20 mg pill is white and round to distinguish it from Viagra's blue diamond-shaped pill for erectile dysfunction. Pfizer expects Revatio to be available in retail pharmacies in mid-July.
Revatio is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. The efficacy of Revatio has not been evaluated in patients currently on bosentan therapy.
The use of Revatio or Viagra and organic nitrates in any form, at any time, is contraindicated. Side effects were similar to the established safety profile of Viagra used for the treatment of ED.
The most common side effects of Viagra are headache, facial flushing and upset stomach. Less commonly, bluish vision, blurred vision or sensitivity to light may briefly occur.
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Source: Pfizer Inc
Revatio, a Viagra Spinoff, Okayed for Pulmonary Arterial Hypertension
By Peggy Peck, Senior Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine.
WASHINGTON, June 7-The FDA has approved Revatio, a new formulation of Viagra (sildenafil), for treatment of pulmonary arterial hypertension (PAH).
In the pivotal trial of the Pfizer drug reported last fall, patients taking 20 mg of Revatio three times daily, which became the FDA-approved dose, increased six-minute walk distance by 45 meters, which was significantly better than patients in the placebo group (P <0.001).
That study enrolled 277 patients with PAH, 38% of whom were New York Heart Association (NYHA) functional class II and 58% were NYHA class III.
Hoissein A. Ghofrani, M.D. of the University of Giessen in Germany, said Revatio improved outcome irrespective of functional class. Dr. Ghofrani was principal investigator of the pivotal trial and he presented the results last October at CHEST 2004.
Joe Feczko, M.D., Pfizer's chief medical officer, said Revatio is the first oral treatment for PAH to be approved for patients with early stage disease.
In addition to improved six-minute walk test results, 35% of patients treated with Revatio improved functional class compared with 7% of patients in the placebo group. Moreover, mean pulmonary arterial pressure (mPAP) decreased by an average of 5.1 mm Hg among Revatio-treated patients, but this was not statistically significant.
Revatio, which the company says will be available next month, is the second oral medication approved for PAH. The first, Trocleer (bosentan), which is manufactured by Actelion Pharmaceuticals, costs about $40,000 for a year of treatment.
The drugs differ in mechanism of action. Trocleer is a novel, nonselective endothelin-receptor antagonist. Revatio is a cyclic GMP phosphodiesterase (PDE) type 5 inhibitor that prolongs the vasodilatory effect of nitric oxide.
Pfizer has not released price estimates for Revatio, but a company statement noted that since only about 100,000 patients worldwide are diagnosed with PAH, the company does not view Revatio as a potential profit center. "Revatio demonstrates our commitment to developing treatments for unmet medical needs, including rare conditions such as PAH, regardless of commercial potential," said Dr. Feczko.
Dr. Feczko also noted that Revatio has not been tested in patients currently treated with Trocleer.
Anticipating the potential for confusion, Pfizer said Revatio 20 mg will be marketed as a white round pill to distinguish it from Viagra, which is a blue diamond-shaped pill. Moreover, since the lowest available dose of Viagra is 25 mg, there is no Viagra dose equivalent to the 20 mg Revatio dose.
Primary source: Food and Drug Administration
Source reference:
Revatio Approved for Pulmonary Arterial Hypertension
MedPage Today Action Points
Pfizer says Revatio will be available by mid-July. Advise patients who ask about using Viagra to treat PAH that there is no equivalent Viagra dose.
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