Receive our newsletter – data, insights and analysis delivered to you
  1. Market Data
November 16, 2011updated 29 Oct 2021 6:21am

Incyte Corps gets first approval for myelofibrosis drug

Incyte Corp's Jakafi (ruxolitinib) has become the first drug to be approved for the treatment of the rare bone marrow disease myelofibrosis.

Incyte Corp’s Jakafi (ruxolitinib) has become the first drug to be approved for the treatment of the rare bone marrow disease myelofibrosis.

Myelofibrosis is a disease in which the bone marrow is replaced by scar tissue. This causes an uncontrollable growth of blood cells in organs such as the liver and spleen, which become enlarged as a result.

The US Food and Drug Administration (FDA) approved Jakafi after two clinical trials showed that patients given the drug experienced more than a 35% reduction in spleen size compared to patients receiving placebo.

A greater proportion of patients receiving Jakafi saw more than a 50% reduction in their myelofibrosis-related symptoms, including abdominal discomfort, itching and bone or muscle pain, than was the case in patients receiving placebo.

Jakafi, a pill taken two times a day, inhibits enzymes called JAK 1 and 2, which are involved in regulating blood and immunological functioning.

Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said, “Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways.

Content from our partners
Extractables and leachables analysis in pharmaceutical quality control
How Hengst helped to keep Germany’s charity “star singers” shining

“The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU