Jazz Pharmaceuticals plc JAZZ announced that the FDA has approved Defitelio (defibrotide sodium) for the treatment of adult and pediatric patients suffering from hepatic veno-occlusive disease (VOD; also known as sinusoidal obstruction syndrome) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). The company’s shares were up 2.6% on the news.
This makes Defitelio the first and only FDA-approved therapy for this rare and life-threatening complication having a mortality rate of 84%. We note that Defitelio enjoys orphan drug status in the U.S. for the treatment of hepatic VOD.
We remind investors that Defitelio is already approved in the EU for the treatment of severe VOD in patients over one month of age undergoing HSCT transplantation therapy. The drug became a part of Jazz's portfolio following the Jan 2014 acquisition of Gentium and has registered sales of $70.7 million in 2015.
We are encouraged by the FDA approval of Defitelio. The company expects to start shipping the product to distribution channels in a week. Approval in the U.S. should boost the drug’s commercial potential further.
We expect investor focus to remain on the commercialization and sales ramp up of Defitelio.
Jazz is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP, Anika Therapeutics Inc. ANIK and Actelion Ltd. ALIOF. All three carry a Zacks Rank #1 (Strong Buy).
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