FDA to Review Alternative Dosing Method for Bone Marrow Drug

redbloodcellsMost people have never heard of myelodysplastic syndrome (MDS), but approximately 10,000 to 15,000 people in the U.S. are diagnosed with it every year. MDS is a group of bone marrow diseases that limit the body’s ability to produce functional blood cells. Common symptoms of MDS include anemia, fever, frequent infections, and easy bleeding or bruising. In more severe cases, the infections and bleeding can become life-threatening. Astronomer Carl Sagan died of complications related to MDS.

Eisai Corporation of Woodcliff Lakes, NJ, is one of the few pharmaceutical companies developing treatments for MDS. The company announced today that the U.S. Food and Drug Administration accepted for review the company’s supplemental new drug application for an alternative five-day dosing regimen for its MDS drug Dacogen. Dacogen is designed to help regulate bone marrow function, increasing the number of healthy blood cells and decreasing the need for blood transfusions. The drug is typically infused over a three-hour period every eight hours, for three consecutive days. Patients need to repeat the treatment cycle every six weeks. The alternative dosing method submitted to the FDA only requires one infusion per day, with a decreased administration time.  If approved, the new method would be more convenient for patients. Drugs such as Dacogen or Celgene‘s Revlimid can help slow the progression of the disease. Last year, Celgene’s Vidaza received expanded approval as the first and only drug with overall survival advantage for high-risk MDS in the U.S. Vidaza had already been FDA-approved since 2003 across all stages of MDS. Another company working in this space is SGX Pharmaceuticals.

Esai of North America is owned by Tokyo-based Eisai Co., producer of top-selling Alzheimer’s drug Aricept. Eisai Co. recently announced plans to expand into emerging markets.

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