FDA Authorizes Emergency Use Of Intravenous Antiviral Peramivir For 2009 H1N1 Influenza For Certain Patients, Settings

Main Category: Swine Flu
Also Included In: Regulatory Affairs / Drug Approvals;  Flu / Cold / SARS;  Infectious Diseases / Bacteria / Viruses
Article Date: 26 Oct 2009 - 4:00 PDT

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The U.S. Food and Drug Administration announced that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

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

1. the patient is not responding to either oral or inhaled antiviral 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 IV therapy is appropriate due to other circumstances.

The FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.

There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.

For more information, see http://www.cdc.gov/h1n1flu/eua/ or call 1-800-CDC-INFO (1-800-232-4636).

Additional Information

- EUA Letter of Authorization
- EUA Fact Sheet for Health Care Providers
- EUA Fact Sheet for Patients and Parents/Caregivers
- Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA

Source
U.S. Food and Drug Administration