Celgene Corp (NASDAQ:CELG) has revealed that the US Food and Drug Administration has refused its application seeking approval of its drug for treating relapsing multiple sclerosis due to insufficient data.
Shares in the company fell 8.45% to US$87.7 in early US deals after saying it received a ‘refusal to file’ letter from FDA for the ozanimod drug.
Last month the group had said it expected to receive US approval of ozanimod by the end of this year. Celgene also planned to file for European approval during the current quarter.
The FDA’s decision will likely delay the company’s entry into market one of its most important pipeline assets.
Jefferies analyst Michael Yee said it was “extremely unlikely that there is an inherent regulatory problem” and saw the development as “merely a delay and yet another shorter term problem”
The FDA found in its preliminary review that nonclinical and clinical pharmacology sections in the new drug application were insufficient to authorise a complete review.
Celgene plans to seek guidance from the FDA to find out what additional information will be needed to resubmit the application.
“We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients,” Jay Backstrom, Celgene’s chief medical officer and head of global regulatory affairs, said in a statement.