Astex Pharmaceuticals Inc. (ASTX) announced Tuesday that the FDA has declined to approve Dacogen for Injection in the additional indication of acute myeloid leukemia in elderly patients who are not considered candidates for induction therapy.
Dacogen is currently approved for the treatment of myelodysplastic syndrome, which is a disease of the blood and bone marrow, and is available in more than 30 countries worldwide including, key markets such as the United States, Brazil, China, India, Russia and Turkey.
Dacogen was licensed by Astex Pharma to MGI Pharma Inc., in August 2004, which in turn, sub-licensed the drug to Janssen-Cilag, a Johnson & Johnson company in July 2006. MGI Pharma was acquired by Eisai Corp of North America in January 2008.
The supplemental New Drug Application for Dacogen for patients with acute myeloid leukemia in adults 65 years of age or older who are not considered candidates for induction therapy, which was submitted by Eisai, was based on a phase III clinical trial (DACO-016) data.
An FDA panel, which reviewed the application, voted 10 to 3 against the new use for Dacogen last month, saying that the drug did not have a favorable benefit-risk profile in the acute myeloid leukemia setting.
In line with the panel's recommendations, the FDA has also declined to approve Dacogen for additional use on the grounds that the pre-specified analysis of the primary endpoint in the study (DACO-016) did not demonstrate statistically significant superiority of Dacogen over the control arm.
The proposal for Dacogen's approval for the treatment of elderly Acute Myeloid Leukemia is under review in the European Union, and the European Medicines Agency is expected to announce its decision later this year.
ASTX closed Tuesday's trading at $1.83, down 4.19%, on a volume of 571,232 shares.
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