BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that it received a preliminary comment letter from the U.S. Food & Drug Administration (FDA) that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of intravenous (i.v.) 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. The FDA also suggested the Company request a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in its preliminary comment letter.
“We are encouraged by these recent communications, and we look forward to advancing our peramivir discussions with the FDA and BARDA/HHS. Our ultimate objective is the approval of peramivir as an intravenous treatment option that could benefit patients in the United States”
BioCryst 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. The notification confirmed that the Biomedical Advanced Research and Development Authority (BARDA/HHS) will continue to support and fund certain activities that are necessary to achieve immediate milestones, as well as activities deemed essential to maintain compliance with FDA regulations or to fulfill pending FDA requests. Following an In-Process Review (IPR) meeting, which BioCryst anticipates in the second quarter, BARDA/HHS is expected to determine the path forward for the contract.
"We are encouraged by these recent communications, and we look forward to advancing our peramivir discussions with the FDA and BARDA/HHS. Our ultimate objective is the approval of peramivir as an intravenous treatment option that could benefit patients in the United States," said Jon P. Stonehouse, President & Chief Executive Officer. "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."