Incyte Inc. reported a late stage study shows Jakafi ( ruxolitinib) is effective in treating a blood disease.
The study used the drug to treat polycythemia vera (PV), a disease affecting 100,000 in the U.S. The findings mean Incyte will seek approval from the Food and Drug Administration for using the drug to treat PV.
Stock in Incyte rose on the news by 3 percent to $52.49. Shares have traded as high as $71 in the past year. Jakafi is the company’s sole drug.
Findings from the study are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology in Chicago.
Incyte is converting a former department store buildng near Wilmington into a headquartes and research center. Jakafi is also being used in treatment of other types of blood disease.
“Patients with advanced PV whose disease is not well-managed with existing therapies are at increased risk for thrombosis and suffer from multiple debilitating symptoms,” stated Srdan Verstovsek, M.D., of the University of Texas MD Anderson Cancer Center. “Data from the Response trial demonstrated that treatment with ruxolitinib can consistently control hematocrit, reduce spleen size, and improve symptoms such as fatigue and itching. Importantly, there appears to be a lower rate of thrombosis (blood clots) in the ruxolitinib arm compared to best available therapy.”
“One out of four patients with polycythemia vera remain uncontrolled, face a profound symptom burden and are at greater risk of cardiovascular complications such as stroke and heart attack,” stated Hervé Hoppenot, CEO Incyte. “These Phase III data give us confidence that ruxolitinib has the potential to become an important new treatment option for patients with uncontrolled PV who are no longer responding to or are intolerant of hydroxyurea.”
Polycythemia vera (PV) is characterized by an overproduction of normal red blood cells, white blood cells and platelets that leads to an increased risk of thrombosis.
PV may occur at any age but often presents later in life, with a median age at diagnosis of 60 years.
The most common signs and symptoms of PV are fatigue, night sweats, bone pain, fever and weight loss. In patients who experience severe and burdensome symptoms, data show that the disease erodes the quality of life.
