See What HealthDay Can Do For You
Contact Us

Jakafi Approved for Rare Bone-Marrow Disease

First drug in U.S. sanctioned for myelofibrosis

WEDNESDAY, Nov. 16 (HealthDay News) -- Jakafi (ruxolitinib) has been approved by the U.S. Food and Drug Administration as the first drug to treat myelofibrosis, a rare disease of the bone marrow, the agency said Wednesday.

In cases of myelofibrosis, healthy bone marrow is replaced by scar tissue, causing blood cells to be made in the liver, spleen, and other organs. Symptoms often include an enlarged spleen, anemia, a decrease in white blood cells and platelets, fatigue, abdominal discomfort, pain under the ribs, muscle and bone pain, itching, and night sweats, the FDA said in a news release.

Jakafi inhibits the actions of two enzymes that are involved in regulating blood, the agency said. The drug was evaluated in clinical studies involving 528 people, all of whom had an enlarged spleen.

Observed side effects included low blood platelet levels, anemia, fatigue, diarrhea, shortness of breath, headache, dizziness, nausea, and confusion.

Jakafi was approved as an orphan drug, since myelofibrosis affects fewer than 200,000 people in the United States, the FDA said.

The drug is produced by Incyte Corp., based in Wilmington, Del.

More information

The FDA has more about this approval.

Physician's Briefing

HealthDay

HealthDay is the world’s largest syndicator of health news and content, and providers of custom health/medical content.

Consumer Health News

A health news feed, reviewing the latest and most topical health stories.

Professional News

A news feed for Health Care Professionals (HCPs), reviewing latest medical research and approvals.