Regeneron Pharmaceuticals said on Friday the U.S. health regulator approved its drug to treat a rare blood disease.
Veopoz – the first treatment to be approved by the U.S. Food and Drug Administration for the life-threatening disease – will be sold in the United States at a list price of $34,615.38 per single-use vial, the company told Reuters in an e-mailed response.According to Regeneron, the disease has fewer than 10 patients identified in the U.S. and estimates less than 100 patients with the condition worldwide.
With Veopoz’s approval, the pre-approval inspection issues related to the marketing application of the higher dose of its blockbuster eye disease drug Eylea has been addressed, the company said. The FDA had in June declined to approve the higher-dose version following an inspection at third-party manufacturer Catalent.
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