US FDA approves new indication for Incyte's Jakafi

The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s (Nasdaq: INCY) Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.

Jakafi’s new use is intended to treat polycythemia vera patients who have an inadequate response to or cannot tolerate hydroxyurea, another medicine often prescribed to reduce the number of red blood cells and platelets in the blood. Jakafi works by inhibiting enzymes called Janus Associated Kinase (JAK) 1 and 2 that are involved in regulating blood and immunological functioning. The drug’s approval to treat polycythemia vera will help decrease the occurrence of an enlarged spleen (splenomegaly) and the need for phlebotomy, a procedure to remove excess blood from the body, the FDA said.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, adding: “The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease.”