Incyte Corporation announced that the U.S. Food and Drug Administration has approved Jakafi for the treatment of patients with polycythemia vera (PV) , a rare blood disease
Jakafi, an oral medication, is the first and only product approved by the FDA for PV, a rare and progressive blood cancer.
Incyte stock rose about 1 percent on Friday, trading near a record $75 a share. The total stock market value of the company is more than $12 billion.
“The approval of Jakafi represents an important advance for patients with uncontrolled PV. For the first time we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume,” said Srdan Verstovsek, M.D., Ph.D., professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.
PV is a typically characterized by an elevated percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count.
PV may occur at any age but often presents later in life.
Approximately 100,000 patients in the U.S. are living with PV. Current standard treatment for PV is phlebotomy (the removal of blood from the body) plus aspirin.
When phlebotomy can no longer control the disease, chemotherapy used. Approximately one in four patients with PV are considered uncontrolled, because they have an inadequate response to or are intolerant of hydroxyurea, the most commonly used chemotherapeutic agent.
The disease can lead to blood clots and cardiovascular death.. Symptoms commonly include fatigue, itching, night sweats, bone pain, fever, and weight loss.
The company is working to find other uses for Jakafi, which is part of a new class of drugs developed by the company, which recently opened a 550-employee headquarters and research center near Wilmington.
In 2011, the company received approval for the use of Jakafi to treat high-risk myelofibrosis, a rare but difficult-to-treat form of blood cancer.
