Pfizer gets Revatio approved by EMEA

Pfizer has announced that the European Medicines Agency (EMEA) has approved its Revatio (sildenafil citrate) drug for the treatment of pulmonary arterial hypertension (PAH).

PAH is a rare, aggressive and life-shortening vascular disease that affects approximately 100,000 people worldwide and is seen most commonly in women between the ages of 20 and 40.

Revatio is classified by the EMEA as an orphan drug. Medicines granted orphan drug status are intended for rare and serious or life-threatening diseases that affect fewer than five in 10,000 persons, or are medicines unlikely to be developed under normal market conditions.

The EMEA approved Revatio for the treatment of patients with PAH classified as WHO (World Health Organization) functional class III, to improve exercise capacity.

In trials Revatio patients showed a 96 per cent survival rate, compared to an expected survival rate of 71 per cent.

“The company is pleased with the European regulatory decision and looks forward to making Revatio available to patients in all member states of the European Union,” said Michael Berelowitz, Pfizer vice president Worldwide Medical.

Sildenafil citrate is the active ingredient in Viagra, Pfizer’s erectile dysfunction medication.

Revatio will be distributed as a white, round 20mg pill to distinguish it from Viagra’s blue diamond-shaped pill for erectile dysfunction, and was approved for the treatment of PAH by the United States Food and Drug Administration(FDA) in June this year.

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