February 27, 2018 / 10:06 PM / a year ago

U.S. FDA rejects filing for Celgene MS drug, shares fall 7 pct

Feb 27 (Reuters) - U.S. health regulators have rejected Celgene Corp’s application seeking approval of a key multiple sclerosis drug due to insufficient data, the company said on Tuesday, a surprise development that will likely delay the entry of one of Celgene’s most important pipeline assets.

Celgene shares fell nearly 7 percent after it revealed that it had received a “refusal to file” letter from the Food and Drug Administration (FDA) for its ozanimod for the treatment of patients with relapsing multiple sclerosis.

Celgene last month had said it expected U.S. approval of ozanimod by the end of this year. (Reporting by Bill Berkrot; Editing by David Gregorio)

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