FDA approves Pfizer gene therapy Beqvez for treatment of hemophilia B [Video]

The Food and Drug Administration on Friday announced that the agency approved Pfizer‘s treatment for a rare genetic bleeding disorder, making it the company’s first gene therapy to win clearance in the U.S. 

The agency greenlighted the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B who meet certain requirements.

The treatment will be available by prescription to eligible patients this quarter, a Pfizer spokesperson told CNBC. It has a hefty $3.5 million price tag before insurance and other rebates, the spokesperson added, making it by far one of the most expensive drugs in the U.S.

More than 7,000 people in the U.S. are living with the debilitating condition, which predominantly affects men, according to an advocacy group. The condition is caused by insufficient levels of a certain proteinthat helps blood clot to stop bleeding and seal wounds. Without that protein, called factor IX, patients with hemophilia B bruise easily …