SUMMIT (dpa-AFX) - The U.S. Food and Drug Administration has approved Impact Biomedicines' Inrebic capsules to treat adult patients with certain types of myelofibrosis.
'Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. Our approval today provides another option for patients,' said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
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
Jakafi was approved by the FDA in 2011. The approval of Inrebic 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 of 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.
Common side effects for patients taking Inrebic are diarrhea, nausea, vomiting, fatigue and muscle spasms.
Impact Biomedicines, Inc., a wholly-owned subsidiary of Celgene Corporation.
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