FDA backs Celgene's rare bone marrow disorder candidate

US biotech major Celgene Corp (Nasdaq: CELG) today announced the US Food and Drug Administration has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

The approval, granted under Priority Review, marks the first clearance of a treatment of this condition in nearly a decade. It will compete with Incyte's (Nasdaq: INCY) Jakafi (ruxolitinib, which was approved by the FDA in 2011, and generated around $1 billion sales in 2018.

"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 Dr Richard Pazdur, 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.