FDA faces decision about use of peramivir for H1N1

Oct 15, 2009 (CIDRAP News) – In response to questions from citizens at a meeting yesterday, a Food and Drug Administration (FDA) official said the agency would make a decision "fairly soon" about permitting emergency use of the experimental antiviral drug peramivir to help patients severely ill with pandemic H1N1 influenza.

The FDA has been reviewing a possible emergency use authorization (EUA) for peramivir, which, like the licensed drugs oseltamivir (Tamiflu) and zanamivir (Relenza), is a neuraminidase inhibitor. Peramivir can be given intravenously (IV) or intramuscularly (IM), whereas oseltamivir is taken orally and zanamivir is inhaled as a powder.

During a public teleconference of the National Biodefense Science Board (NBSB) yesterday, Aubrey Miller of the FDA Office of Counterterrorism was asked to comment on the status of the FDA's review of an EUA for peramivir for H1N1 patients. The NBSB is an advisory board to the Department of Health and Human Services (HHS).

"There should be information or decisions being made fairly soon. That amongst other medical countermeasures are currently being evaluated by the agency," Miller said. "I don't have a specific time frame at this time, because things are under review."

Board members asked Miller for a status report after several people asked about peramivir during a public comment portion of the 2-hour meeting.

A man who identified himself as Paul Gordon of San Francisco asserted that there is "an incredible need" for an IV antiviral for patients in intensive care because of H1N1 flu. He noted that the drug can be used currently in individual patients under an emergency use investigational new drug (IND) procedure, but said the Centers for Disease Control and Prevention (CDC) Web site provides no information about this option. Gordon asserted that the drug has already "saved multiple individuals' lives."

Catherine Collier Kyroulis, a spokeswoman for BioCryst Pharmaceuticals, maker of peramivir, said today the company has had 20 requests from physicians to use the drug in H1N1 patients under the emergency-use IND rules. She said information on the outcomes of those cases was unavailable.

Physicians who want to use peramivir under the emergency IND rules must contact BioCryst for an evaluation of the case and then fill out an application, according to the company. The request also must go through the appropriate institutional review board (IRB), said Karen Riley, an FDA spokeswoman. The arrangements must be authorized by the FDA.

In September HHS asked BioCryst to submit a proposal to supply between 1,000 and 40,000 doses of peramivir under an EUA, the company reported on Sep 21. The HHS request for proposal did not guarantee that HHS would actually order the doses or issue an emergency authorization, the company said.

The NBSB heard comments and questions from two other people about peramivir during yesterday's teleconference.

A man who described himself as a concerned parent in Texas expressed impatience with the FDA. With the H1N1 vaccine not yet widely available and with severe cases occurring in children, he said, "To me it's unacceptable that FDA can't comment on this. BioCryst has been working with FDA since April on this. I don't understand what the holdup is."

Also, a man identifying himself as a teacher from Los Angeles wanted to know about a rumor that peramivir has been effective in hospitalized H1N1 patients.

NBSB members did not reply to the citizen questions other than by asking Miller for a status report on the FDA review.

The peramivir issue has come up at previous NBSB meetings. At a session on Aug 14, board members and citizens expressed concern about the lack of an IV or IM antiviral for flu patients and urged HHS officials to strongly consider issuing an EUA.

BioCryst is currently preparing to launch two phase 3 clinical trials of IV peramivir. In September the company received a $77.2 million HHS contract modification to complete phase 3 development. The company's original contract was a $102 million award in 2007.

"Based on the recent stats on number of H1N1 cases we would assume that patients with H1N1 will be included in the [phase 3] trials," said Kyroulis.

See also:

Sep 21 BioCryst press release on HHS request for proposal to supply peramivir
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=410328

Sep 21 BioCryst press release on $77 million contract modification
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=410327

CDC info on EUAs
http://www.cdc.gov/h1n1flu/eua/

FDA information about access to investigations drugs outside of a clinical trial
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

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