By Michael Dabaie

The U.S. Food and Drug Administration granted Celgene Corp. (CELG) subsidiary Impact Biomedicines Inc. approval of Inrebic capsules to treat adults with certain types of myelofibrosis, a rare bone marrow disorder.

The approval of Inrebic, or fedratinib, for intermediate-2 or high-risk primary or secondary myelofibrosis was based on the results of a clinical trial where 289 patients with myelofibrosis were randomized to receive two different doses fedratinib or placebo. The clinical trial showed that 35 of 96 patients treated with the fedratinib 400 mg daily dose experienced a significant therapeutic effect, the FDA said in a release.

Myelofibrosis is a chronic disorder where scar tissue forms in the bone marrow and the production of the blood cells moves from the bone marrow to the spleen and liver, causing organ enlargement. It can cause extreme fatigue, shortness of breath, pain below the ribs, fever, night sweats, itching and bone pain.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

August 16, 2019 10:59 ET (14:59 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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