Eisai says 5-day bone marrow disease drug treatment approved; 3-day regimen approved in 2006

Eisai says FDA approved new Dacogen dosing

WOODCLIFF LAKE, N.J. — Drugmaker Eisai Inc. said the Food and Drug Administration approved a new, longer dosing regimen of its bone marrow disease treatment Dacogen.

Eisai said the FDA cleared a five-day regimen of Dacogen as a treatment for myelodysplastic syndrome. The drug, which was developed through a partnership between SuperGen Inc. and MGI Pharma, was approved in May 2006 in a three-day dosing regimen. The new approval was announced late Thursday.

Myelodysplastic syndrome affects the production of blood cells.

The new regimen is intended for outpatient use: patients can get a larger dose of Dacogen once per day for five days, repeated once every four weeks. Previously the drug was given for three days. Each dose was given over a three-hour period, with eight-hour breaks between doses.

Eisai, a Japanese drugmaker, acquired MGI Pharma in early 2008. SuperGen is based in Dublin, Calif.