The bone marrow of people with myelofibrosis is replaced by scar tissue, which can cause an enlarged spleen, anemia, decreased white blood cells and platelets. Jakafi, which is taken twice a day, inhibits the enzymes involved in regulating blood and immunological functioning.
Incyte said the drug will be available next week and the company has established a financial assistance program for patients who qualify.
"This milestone marks a tremendous achievement for Incyte because a scientific discovery from our research laboratories has become the first JAK inhibitor to reach the market and provide a clinical benefit to patients," said President and Chief Executive Paul A. Friedman.
Known generically as ruxolitinib, Jakafi is the first drug to reach the market from Wilmington, Del.-based Incyte Corporation. The company has partnered with Swiss drugmaker Novartis, which holds the rights to market Jakafi abroad. The company said Wednesday that Jakafi will cost $7,000 per month, or $84,000 for a year's supply for insured patients. Incyte plans to provide the drug free to uninsured patients and will offer co-pay assistance to patients with financial need.
The FDA approved the drug based on two studies including 528 patients with the disease. Patients were randomly assigned to receive a placebo or Jakafi. More patients in the drug group saw a significant reduction in the size of their spleen as well as a 50 percent decrease in symptoms, including pain, discomfort and night sweats.
The drug works by blocking two enzymes associated with the disease.
The FDA reviewed Jakafi under its priority review program for important new therapies, which aims to clear drugs in six months instead of the usual 10.
Side effects reported in patients taking the drug included diarrhea, headache, dizziness and nausea.
Company shares rose 97 cents, or 7.7 percent, to $13.57 in midday trading.
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