(Reuters) - The U.S. Food and Drug Administration has cleared Jazz Pharmaceuticals Plc’s drug to treat a rare kind of liver disease, making it the first treatment to win U.S. approval for the condition.
The drug, defibrotide, targets patients with hepatic veno-occlusive disease (VOD), a potentially fatal complication of stem-cell transplantation in which some of the veins in the liver become blocked, causing swelling and a decrease in blood flow inside the liver.
The disease can lead to liver damage, and in its most severe form patients develop failure of the kidneys and lungs, the FDA said on Wednesday. (1.usa.gov/22OUuDb)
Shares of Jazz were up 3.4 percent at $124.94 on the Nasdaq.
Out of the nearly 20,000 stem cell transplantation procedures done in the United States annually, about 8.8 to 13.8 percent of the patients suffer from severe VOD, Stifel Nicolaus analyst Annabel Samimy said, citing a published research.
Samimy said she expects the drug to be launched in the United States immediately.
Defibrotide, which was added to the drugmaker’s pipeline through the acquisition of Gentium SpA, is already available in Europe and is marketed under the brand name Defitelio. Defitelio raked in sales of about $70.7 million in 2015.
Defitelio and Defibrotide could add up to $6.64 to Jazz’s profit per share in 2016, Guggenheim Securities LLC’s Louise Chen wrote in a note dated Feb. 22.
Defibrotide’s sales could also help lower Ireland-based Jazz’s tax rate, Chen added.
Reporting by Samantha Kareen Nair and Amrutha Penumudi in Bengaluru; Editing by Maju Samuel