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Celgene MS drug application rejected by US FDA

The U.S. Food and Drug Administration rejected the new drug application for Celgene Corp.'s experimental multiple sclerosis treatment ozanimod.

Ozanimod is in development for the treatment of patients with forms of multiple sclerosis that return after treatment.

The regulatory authority handed the rejection via a refusal-to-file letter after concluding that the nonclinical and clinical pharmacology sections in the application were insufficient to conduct a complete review.

A refusal-to-file letter is based on omissions of clearly necessary information.

The Summit, N.J.-based drugmaker plans to seek immediate guidance, including requesting a meeting with the FDA, to determine what additional information will be required to resubmit the application.

Jay Backstrom, the company's chief medical officer and head of global regulatory affairs, said the company was "confident" in ozanimod's clinical profile shown in its clinical trial and plans to work with the FDA to "expeditiously address all outstanding items".

Previously, analysts said they expected ozanimod to become Celgene's pipeline priority and a meaningful contributor to long-term revenue.