BioCryst's investigational H1N1 drug granted Emergency Use OK Print E-mail
By Staff and Wire Reports   
Saturday, 24 October 2009 06:51

After market hours on Friday, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA), in response to a request from the U.S. 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 pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

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Specifically, i.v. peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the following reasons:

  1. the patient is not responding to either oral or inhaled anti-viral therapy, 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 to be dependable or feasible;
  3. for adults only, when the clinician judges i.v. therapy is appropriate due to other circumstances.

Additional information regarding the peramivir EUA is available on the Web at:

www.cdc.gov/h1n1/eua

In advance of any U.S. 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 U.S. 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."

A recent New York Times article points out that Peramivir is a drug that works the same way as Tamiflu and Relenza but is given intravenously.

An infusion of the drug delivers a quick jolt of drug to desperately ill patients who cannot swallow Tamiflu capsules or inhale Relenza.

A study conducted in Asia showed that a single 15- to 30-minute infusion of peramivir was equivalent to a five-day course of Tamiflu in alleviating symptoms of the seasonal flu.

Dr. Frederick G. Hayden, a virologist at the University of Virginia, said intravenous administration ''gives a high concentration in the plasma rapidly and makes a lot of sense.'' But he said peramivir did not appear to work that well against infections resistant to Tamiflu.



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