(Adds details on drug, background)
LONDON, Feb 21 (Reuters) - Italian biotech company Gentium
has failed to convince European regulators of the benefits of its most advanced drug candidate, dealing a blow to prospects for the rare liver disease treatment.
Gentium said on Thursday it expected an opinion recommending against approval of defibrotide from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
"While not a final decision, the company considers it unlikely that this position will change before the formal vote is undertaken next month," Gentium added in a statement.
"If a formal negative recommendation is issued, and depending upon the nature of the objections, the company may appeal such negative decision."
Investor hopes have been pinned on defibrotide since it would be the first drug approved for hepatic veno-occlusive disease (VOD), a rare a condition in which some veins in the liver are blocked as a result of cancer therapy given prior to stem cell transplants.
Gentium's drug, based on single-stranded DNA extracted from pig intestines, has not yet been approved by the U.S. Food and Drug Administration.
(Reporting by Ben Hirschler; editing by Andrew Callus)
((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))
Keywords: GENTIUM EUROPE/
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