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Treatment for bone marrow diseases receives FDA approval for new dosing regimen

Posted On Tue, March 16, 2010

The U.S. Food and Drug Administration has approved a new dosing regimen for a medication designed to treat patients who suffer from a certain set of bone marrow diseases that alter the production of functional blood cells.

Dacogen, a hypomethylating agent that was designed for injection into patients suffering from myelodysplastic syndromes that was created by Eisai Inc., was approved last week by the FDA for a five-day dosing regimen. The treatment had only previously been approved for a three-day regemin.

"The approval of Dacogen offers doctors and patients the flexibility of choosing the most appropriate dosing regimen for an individual patient," said Steven C. Sembler, Senior Vice President of Commercial U.S. Pharmaceuticals at Eisai. "This important milestone demonstrates our commitment to furthering Eisai's human health care mission of increasing benefits for patients and their families."

Myelodysplastic syndromes primarily affect men over the age of 60 and can result in anemia, neutropenia, and/or thrombocytopenia that can lead to fatigue, shortness of breath, infections, bruising and bleeding.

While the new dosing regimen may create a more appropriate method of treating some MDS patients, its status as a newer treatment me preclude it from being covered by some health insurance plans that prefer more established treatments. Before beginning any treatments, one should always make sure their insurance covers the costs associated with it, or seek out a plan that does provide the appropriate coverage.ADNFCR-2297-ID-19672338-ADNFCR

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