Emergency Use Authorization Granted For BioCryst's Peramivir
Mon, 10/26/2009 - 4:33am
BioCrystPharmaceuticals, Inc. recently announced that the FDA, in response to a request from the U.S. Centers forDisease Control and Prevention (CDC), has issued an emergency useauthorization (EUA) for the investigational anti-viral drug intravenous (i.v.)peramivir in certain adult and pediatric patients with confirmed or suspected2009 H1N1 influenza infection who are admitted to a hospital.Specifically, i.v. peramivir is authorized only for hospitalized adult andpediatric patients for whom therapy with an i.v. drug is clinicallyappropriate, based on one or more of the following reasons: 1. the patient is not responding to either oral or inhaled anti-viraltherapy, or 2. when drug delivery by a route other than an intravenous route -- e.g.,enteral (absorbed by the intestines) or inhaled -- is not expected tobe dependable or feasible; 3. for adults only, when the clinician judges i.v. therapy is appropriatedue to other circumstances. Additional information regarding the peramivir EUA is available on the Webat:www.cdc.gov/h1n1/eua In advance of any U.S. Government order that may come from the ongoingrequest for proposal (RFP) negotiations, BioCryst has donated and transferredto the Department of Health and Human Services (HHS) an initial supplysufficient for 1,200 courses of i.v. peramivir 600 mg once-daily for fivedays. This transfer was made under the development contract with HHS to allowdoctors and patients near-term access to the drug, and is separate from theRFP process. "The issuance of this EUA is important because it makes peramivir atreatment option for physicians in the U.S. during the ongoing influenzahealth emergency," said Jon P. Stonehouse, Chief Executive Officer atBioCryst. "BioCryst has worked with HHS to enable the Government to rapidlydeploy an initial supply of peramivir, and we are prepared to deliver more."To prepare for peramivir orders that BioCryst may receive from the U.S. orother governments during this pandemic emergency, BioCryst is completingproduction of approximately 130,000 courses of i.v. peramivir and is preparedto make more, if required.