Peramivir's Authorization May Signal Rush of Additional H1N1 Experimental Treatments Print E-mail
By Peter DePalma   
Monday, 02 November 2009 18:38

The Food and Drug Administration (FDA) today officially announced the issuance of an Emergency Use Authorization (EUA) for BioCryst Pharmaceuticals, Inc's (NASDAQ:BCRX) peramivir for intravenous (IV) administration in certain adult and pediatric patients.

But the director of the FDA's division of antiviral products is urging caution in the use of a new flu drug that just won special permission to fight H1N1, according to a report from Mike Huckman of CNBC.

In an Op-Ed piece in "The New England Journal of Medicine" the FDA's Dr. Debra Birnkrant writes that "alternatives should be considered."

Dr. Birnkrant points out that peramivir remains formally unapproved and adds, "No conclusions about efficacy can be drawn" from previous studies of peramivir on the seasonal flu. "There are very limited data available regarding the use of peramivir in seriously ill hospitalized patients."

While Peramivir is not approved, the FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir.

Peramivir is one of three flu-fighting drugs available to combat H1N1, but is the only IV treatment.

Tamiflu (oseltamivir phosphate) is available as capsules and as a powder for oral suspension.  RELENZA is for administration to the respiratory tract by oral inhalation only.

Vienna, Virginia based Cel-Sci (Amex:CVM), is developing a novel H1N1 program directed at helping very sick patients infected with H1N1.  Unofficially, those familiar with the accelerated program report that a great deal of positive progress has been made. The company's new drug is based on CEL-SCI’s L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) technology which allows them to direct an immune response against a specific disease epitope, in this case non-changing regions of H1N1.  This would make it the only drug designed to avoid the problem of cytokine storm which is very much involved in the death of most H1N1 patients. When contacted for a comment, officials said CEL-SCI expects to make formal updated announcements on the program very soon.

Given the nature of the pandemic, it is not unrealistic to expect that other novel drugs could be rushed through human trials and approved for use since the public health emergency involving Swine Influenza has the significant potential to affect national security, according to documents released to the news media by the FDA on Monday. The basis of such determination justified the authorization of the emergency use of Peramivir, subject to the terms of any authorization issued under the act.


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