General Information

AGRYLIN (anagrelide HCI) is the first drug approved for the treatment of essential thrombocythemia, a life-threatening condition characterized by elevated blood platelet counts. This condition results in an abnormally high incidence of adverse events associated with thrombosis (blood clotting), including heart attack and stroke. AGRYLIN is indicated for the treatment of essential thrombocythemia to reduce elevated platelet counts and the risk of thrombosis. Associated symptoms are also improved.

Until now, unapproved therapies have been employed to treat excessive platelet counts, but they have distinct disadvantages that include: leukopenia (reduction in white cells); anemia (reduction in red cells); and in some therapies, suspected leukemogenesis (development of leukemia). Because of these potentially serious side effects, clinicians have been particularly reluctant to treat young adults with unapproved therapies.

In contrast, at therapeutic doses, AGRYLIN does not produce significant changes in white or red cell counts and has not been shown to be leukemogenic. The drug’s labeling provides guidelines for treatment of asymptomatic young adults with essential thrombocythemia.

Clinical Results

A total of 551 patients with essential thrombocythemia were treated with AGRYLIN in three clinical trials. The most frequently reported adverse reactions to AGRYLIN were mild and self-limiting and included headache, palpitations, diarrhea, and abdominal pain. More than 2,300 patients in the U.S. have been receiving the drug under a compassionate protocol.