Jazz heads to the FDA with its $1B rare disease drug

Jazz Pharmaceuticals ($JAZZ) has kicked off a rolling FDA submission for defibrotide, a rare disease treatment acquired in its $1 billion buyout of Gentium. The drug is designed to treat patients with severe hepatic veno-occlusive disease who are undergoing hematopoietic stem-cell transplantation therapy. Jazz expects to conclude the application in the first half of next year. The FDA has granted defibrotide its fast-track designation, which guarantees a speedy path through the regulatory process. More

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