CELG Celgene Corporation

   By Colin Kellaher 
 

Celgene Corp. (CELG) on Tuesday said the U.S. Food and Drug Administration accepted and granted priority review to the company's new-drug application for fedratinib for the treatment of the bone-marrow disorder myelofibrosis.

The Summit, N.J., biopharmaceutical company said fedratinib represents the first potential new treatment option for myelofibrosis, which disrupts the body's normal production of blood cells, in many years.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Celgene, which in January announced a deal to be acquired by Bristol-Myers Squibb Co. (BMY), said the FDA has set a target action date of Sept. 3.

Celgene said it also plans to evaluate fedratinib in combination with luspatercept, which it is jointly developing with fellow biopharmaceutical company Acceleron Pharma Inc. (XLRN).

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 05, 2019 08:04 ET (13:04 GMT)

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