Roberts' Anagrelide is Approvable, Says FDA

Roberts Pharmaceutical's New Drug Application for Agrylin (anagrelidehydrochloride), its new product for the treatment of essential thrombocythemia, now has approvable status, according to the US Food and Drug Administration.

The company notes that anagrelide is the first drug to be approved for essential thrombocythemia, a life-threatening condition characterized by high blood platelet counts, caused by overproduction of progenitor megakaryocytes. Current treatment of the condition is normally by radiotherapy or cytotoxic drugs.

Trials have shown that treatment with anagrelide reduces the elevated platelet count, cuts the risk of thrombosis and improves symptoms. Roberts says it has submitted final labeling proposals to the FDA, and anticipates marketing the drug in the near-term.