BioCryst Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA), in response to a request from the US Centers for Disease Control and Prevention (CDC), has issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (i.v.) peramivir in certain adult and paediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
Specifically, i.v. peramivir is authorized only for hospitalized adult and paediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the reasons - the patient is not responding to either oral or inhaled anti-viral therapy; when drug delivery by a route other than an intravenous route – e.g; enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible; and for adults only, when the clinician judges i.v. therapy is appropriate due to other circumstances.
In advance of any US Government order that may come from the ongoing request for proposal (RFP) negotiations, BioCryst has donated and transferred to the Department of Health and Human Services (HHS) an initial supply sufficient for 1,200 courses of i.v. peramivir 600 mg once-daily for five days. This transfer was made under the development contract with HHS to allow doctors and patients near-term access to the drug, and is separate from the RFP process.
"The issuance of this EUA is important because it makes peramivir a treatment option for physicians in the US during the ongoing influenza health emergency," said Jon P Stonehouse, chief executive officer at BioCryst. "BioCryst has worked with HHS to enable the Government to rapidly deploy an initial supply of peramivir, and we are prepared to deliver more."
To prepare for peramivir orders that BioCryst may receive from the US or other governments during this pandemic emergency, BioCryst is completing production of approximately 130,000 courses of i.v. peramivir and is prepared to make more, if required.
Peramivir is an anti-viral agent that was discovered by BioCryst which inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host.
BioCryst Pharma designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases.