The United States Food and Drug Administration (FDA) has issued a Refusal to File letter to Celgene Corporation (NASDAQ:CELG). The letter outlines the company’s marketing New Drug Application (NDA) for Ozanimod, which the agency says the nonclinical and clinical pharmacology sections are insufficient. Thus they, do not meet the requirements of a full review.
Ozanimod is a novel, oral and the approval of its NDA would have given patients with relapsing forms of multiple sclerosis an alternative form of treatment. Apparently, it was one of Celgene’s key pipeline prospects but the company will now have to oblige to FDA demands for additional information.
Request for immediate guidance by the drugmaker
It is clear that the FDA blow delay is a setback to Celgene given that it comes at a time when the company was beginning to rack in potentiality overseas. It was arguably the most important asset in Celgene’s latest pipeline. However, the decline could also be a blessing in disguise.
Through its Chief Medical Officer Jay Backstrom, Celgene says it will cooperate with the FDA in addressing the outstanding concerns on the NDA. The drugmaker confirms that it will be seeking guidance from the agency on how to resubmit the information needed.
Backstrom quotes, “We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients.”
Will the FDA’s non-refusal to review Celgene’s NDA have any impact on the company?
Celgene was quickly winning the confidence of investors as well as making a name for itself in the market. However, the news from the FDA has triggered a lot of uncertainty and credibility questions. Investors are somewhat worried and at the same time, Celgene’s stock fell 6% in after-hours trading.
However, the management says that the FDA’s action is unconnected to potential worries and that they have ongoing clinpharm programs, which would help in addressing FDA’s feed’s feedback.
Meanwhile, Merck & Co., Inc. (NYSE:MRK) has also received refusal-to-file notices previously when it was seeking approval for cardiovascular combination Liptruzet. Another is Genentech, which was asked to refix the filing of its Kadcyla. However, both cases won approvals after fixing their NDA’s.