Astex Pharmaceuticals Inc. said Friday that European Union regulators recommended approving its drug Dacogen as a treatment for acute myeloid leukemia in seniors.
An advisory panel recommended approving the drug for use in patients 65 years and older who are newly diagnosed with the disease or who have previously been treated. Astex said the companies expect regulators to make a decision on the drug by the end of September.
Dacogen is also used to treat myelodysplastic syndrome, a blood and bone marrow disease. Johnson & Johnson’s Janssen-Cilag International business sells the drug outside of North America.
In February, a Food and Drug Administration advisory panel said Dacogen should not be approved to treat acute myeloid leukemia in the U.S.
Shares of Astex advanced 30 cents, or 13.5 percent, to $2.52 on Friday. The stock picked up 6 cents, or 2.4 percent, to $2.58 in aftermarket trading.