Keywords: Pfizer, Revatio, Pulmnary arterial hypertension, European approval

European Commission OKs new IV form of Pfizer’s Revatio for pulmonary arterial hypertension

Article | 6 January 2010

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The European Commission has approved global drug behemoth Pfizer’s Revatio (sildenafil) solution for injection for patients who are currently prescribed oral Revatio and who are temporarily unable to take oral medicine, but are otherwise clinically and hemodynamically stable. Pfizer’s shares rose 3% to $18.75 on the news.

Revatio is the only phosphodiesterase 5 (PDE5) inhibitor with both oral and IV formulations approved in the European Union for the treatment of PAH, the company noted. The injectable PAH drug, whose active ingredient sildenafil is the same as that in Pfizer’s blockbuster erectile dysfunction drug Viagra, was also cleared by the US Food and Drug Administration in November last year.

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“Pulmonary arterial hypertension is a life-threatening disease, and medical treatment can help delay damage caused by the disease,” said Jean-Luc Vachiery, professor of cardiology and director of the Pulmonary Vascular Diseases Unit at Clinique Universitaire De Bruxelles Hopital Erasme (Erasme Hospital) in Belgium and former chairman of the Working Group on Pulmonary Circulation and Right Ventricular Function of the European Society of Cardiology. “Now with the approval of Revatio solution for injection, we have an option to bridge interruptions in treatment of adult patients who may be temporarily unable to take this important therapy in tablet form,” he added.

For some patients, continued 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 or tolerate an oral formulation is important to preserving health in patients with PAH. Revatio solution for injection is for adult patients with PAH who are stable on Revatio tablets but who are temporarily unable to take oral medication and for whom the physician considers continuity of treatment to be in the patients’ best interest.