First Approval For Genetics Institute's Neumega

Genetics Institute says that it has received approval, its first, fromthe US Food and Drug Administration for its platelet growth factor Neumega (oprelvekin). A spokesperson for the company told the Marketletter that Neumega is expected to be launched in January next year.

The drug, which was recommended for approval earlier this year (Marketletter August 4), is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with solid tumors or lymphoma who are at high risk of severe thrombocytopenia. The product is administered as a daily subcutaneous injection at a dose of 50mcg/kg/day following completion of chemotherapy.

In a Talk Paper, the FDA said that patients who have previously received platelet transfusions after chemotherapy would benefit most from the drug, and added that Neumega is not effective for patients undergoing bone marrow transplants.