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FDA Official Urges Caution on New H1N1 Drug
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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.
Two weeks ago the FDA gave Emergency Use Authorization for the IV drug peramivir from BioCryst Pharmaceuticals [BCRX
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The EUA allows doctors to ask the CDC for access to the drug for use only on certain hospitalized pediatric and adult patients.
But the FDA's Dr. Debra Birnkrant, in an Op-Ed piece in "The New England Journal of Medicine" writes, "Alternatives should be considered."
She 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," Dr. Birnkrant writes.
Peramivir is the third flu-fighting drug available to combat H1N1, but is the only IV treatment. Roche [RHBBY
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In an email, a BioCryst spokesman tells CNBC the NEJM article "should help improve awareness of peramivir and the EUA in the medical community. Hopefully, peramivir will reach a greater portion of hospitalized patients...." The company says it's prepared to deliver up to 130,000 courses of the drug by the end of this year.
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