Pharmaceutical

FDA issues authorization for investigational N1H1 drug

Spurred by a request by the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral intravenous drug peramivir for use in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza (swine flu) who are admitted to the hospital.

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

1. The patient is not responding to either oral or inhaled antiviral therapy,
2. When drug delivery by a route other than intravenously, such as enteral (absorbed by the intestines) or inhaled, is not expected to be dependable or feasible,
3. In adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

The FDA has reviewed the available scientific data on the medication 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.

EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or their uses 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.

Given the limited safety data on peramivir, mandatory reporting requirements are in place to help define the safety profile of this unapproved drug. Healthcare providers must report adverse events and all medication errors associated with peramivir to the FDA’s MedWatch program within seven days from the onset of the adverse event.