Pfizer Inc. (PFE), Thursday announced that the European Commission has approved conditional marketing authorization for one-time gene therapy Durveqtix.
The gene therapy is designed for adult patients with hemophilia B, a rare genetic bleeding disorder that prevents normal blood clotting because of a deficiency in factor IX or FIX.
The approval is based on results from the pivotal Phase 3 BENEGENE-2 study, which demonstrated a statistically significant decrease in annualized bleeding rate for total bleeds.
The company said that the authorization is valid in all 27 European Union member states, as well as in Iceland, Liechtenstein, and Norway.
The gene therapy has also recently received regulatory approvals from the U.S. Food and Drug Administration and the Health Canada, where it is marketed as Beqvez.
Currently, Pfizer's stock is trading at $30.45, up 1.58 percent on the New York Stock Exchange.
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