Jakafi Now Indicated to Treat Chronic Graft vs. Host Disease

Jakafi® (ruxolitinib) is now FDA approved to treat chronic graft-versus-host disease (cGVHD) in patients who are at least 12 years old and have failed treatment with one or two lines of systemic therapy.

  • Graft-versus host disease occurs when stem cells from donated bone marrow attack healthy cells in the recipient’s body. It can be acute (occurring within 100 days of the transplant) or chronic (occurring 100 days or more after the transplant).
  • In addition to treating cGVHD, Jakafi is also indicated to treat acute graft-versus-host disease, polycythemia vera (a type of blood cancer), and intermediate or high-risk myelofibrosis (a type of bone marrow cancer).
  • The recommended starting dose for the new indication is 10mg taken by mouth twice daily. The daily dose may need to be reduced based on patient response and other clinical
  • Jakafi, which is made by Incyte, first received FDA approval in

Opzelura Cream Approved to Treat Atopic Dermatitis

Opzelura™ (ruxolitinib) cream, manufactured by Incyte, has won U.S. FDA approval to treat mild to moderate atopic dermatitis in non-immunocompromised patients ages 12 years and up.

  • Indicated for short-term and non-continuous chronic treatment, Opzelura is approved only for use in patients whose disease is not adequately controlled with other topical prescription therapies or for whom those therapies are inadvisable. It is the first topical formulation in a drug class known as JAK inhibitors to receive FDA approval.
  • Recommended dosing is a thin layer applied to affected areas of the skin twice daily. The cream should not be used on more than 20% of the body surface and no more than 60g should be used per week.
  • Opzelura has a wholesale acquisition cost (WAC) of $1,950 per 60g tube.