BioCryst Pharmaceuticals, Inc. (BCRX), Monday said it received a preliminary comment letter from the U.S. Food & Drug Administration providing a pathway by which BioCryst could file a New Drug Application seeking approval of its intravenous, investigational anti-viral agent peramivir. The letter was sent in response to questions BioCryst submitted to the FDA in advance of an upcoming Type C regulatory meeting regarding i.v. Peramivir, added the company.
The FDA has further suggested that BioCryst request a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in its preliminary comment letter.
BioCryst further said it also received written notification from the Department of Health and Human Services in the form of a Stop-Work Order directing the company to cease work on peramivir under its U.S. Government contract, except for certain activities primarily related to the upcoming FDA Type C meeting which is scheduled.
Commenting on the development, Jon Stonehouse, CEO of BioCryst said, "The Stop-Work Order is understandable, as it focuses the scope of reimbursable activities to those that are essential and supportive to continuing regulatory communications, with the objective of preparing an NDA submission. If the conversations with the FDA and BARDA/HHS are successful, BioCryst stands ready to file an NDA for peramivir as soon as feasible."
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