FDA Grants Approval to Celgene's Impact for Bone Marrow Disorder Treatment
August 16 2019 - 11:14AM
Dow Jones News
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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