FDA Approves Intravenous Formulation Of Pfizer's Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals;  Cardiovascular / Cardiology
Article Date: 23 Nov 2009 - 4:00 PST

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Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication.

Pulmonary arterial hypertension is a rare, progressive disease that affects an estimated 100,000 men and women worldwide. This incurable disease is characterized by continuous high blood pressure in the pulmonary arteries, often leading to heart failure and premature death. Pulmonary arterial hypertension can occur with no known underlying cause, or it can occur in association with other disorders.

Due to the chronic nature of pulmonary arterial hypertension, maintaining medical therapy can delay clinical worsening for patients. However, in some cases, oral medication may not be an option for a period of time. While oral treatment can often be re-introduced at a later stage, the ability to maintain treatment during periods when the patient is unable to take an oral formulation is important to preserving health in patients with pulmonary arterial hypertension.

"The approval of Revatio Injection is a clear demonstration of Pfizer's commitment to developing treatments addressing the unmet needs of patients with pulmonary arterial hypertension," said Dr. Cara Cassino, vice president of pulmonary vascular disease, clinical development and medical affairs, Pfizer. "This important milestone highlights the Specialty Care business unit's dedication to advancing treatments for serious and life-threatening conditions such as pulmonary vascular disease."

About Revatio

Revatio Tablets were approved by the FDA in June 2005 and by the European Medicines Agency (EMEA) in November 2005. The American College of Chest Physicians recommends Revatio for adult pulmonary arterial hypertension patients in functional class II and III in its clinical practice guidelines for the treatment of pulmonary arterial hypertension.

Revatio Injection will be supplied in a single-use vial. The recommended dose of Revatio Injection is 10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. Revatio is also available as a 20 mg tablet taken three times a day.

Source
Pfizer Inc