Orphan drug designation for Virexxa in US

Pharmsynthez today announced that the United States Food and Drug Administration (FDA) has unanimously awarded Virexxa, OJSC Pharmsynthez’s treatment for hormonotherapy-resistant endometrial cancer (a malignant tumor of the female reproductive system), orphan drug designation.

Virexxa is the first Russian pharmaceutical to be awarded the status of orphan drug in the United States. The market capacity for this product in the US is estimated at US$ 500 million per year. The FDA made its decision based on a positive ruling by the Committee for Orphan Medicinal Products that combined therapy based on Virexxa can provide considerable clinical advantage to patients with endometrial cancer that is resistant to hormonotherapy.