FDA Gives Premavirin Emergency Authorization to Treat H1N1 Flu Virus

Over the years, doctors have worked to educate the public that antibiotics do not work against a virus. At the same time, researchers were working to find newer and more effective anti-viral drugs. Friday, Federal Drug Administration (FDA) gave one anti-viral Emergency Use Authorization (EUA) to treat severe H1N1 patients.

Peramivir is an IV anti-viral medication that is still in the investigational stages. Usually, this drug would still be waiting on release for public use. However, the need for anti-viral drugs to treat the H1N1 virus led the FDA to provide Premavirin an Emergency Use Authorization (EUA). Examiner.com reports:

"On October 23rd, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for use of the unapproved "investigational antiviral drug peramivir intravenous(IV) in certain adult and pediatric patients" with "confirmed or suspected" severe H1N1 swine flu symptoms when hospitalized." (Emergency use of antiviral IV medication for H1N1 Swine Flu symptoms approved by FDA, 2009)

Peramivir was developed to treat influenza. Peramivir is an anti-viral developed by BioCryst Pharmeceuticals to treat influenza. Peramivir is in testing around the world. BioCryst is developing an injectable version of Peramivir. Injectable Peramivir is in Phase II testing in both South Korea and Japan.

FDA's Emergency Use Authorization (EUA) did not give Peramivir the ability to be used in all H1N1 cases. Centers for Disease Control (CDC) describes situations that warrant use of Peramivir as:

"IV peramivir may be appropriate for certain hospitalized and critically ill patients with suspected or confirmed 2009 H1N1 influenza, such as patients not responding to either an oral or inhaled antiviral therapy and patients without a dependable oral or inhaled route of drug delivery (e.g. patients unable or unlikely to absorb oseltamivir due to ileus or high nasogastric tube output)." (Antiviral Treatment Options, including Intravenous Peramivir, for Treatment of Influenza in Hospitalized Patients for the 2009-2010 Season, 2009)

FDA's Emergency Use Authorization (EUA) begins several important steps that allow Peramivir to be available when needed. FDA's Emergency Use Authorization allows the government to stockpile the drug. Stockpiling aids to ensure that proper quantities are available when needed. It is also important to remember that other parts of the world watch FDA actions. FDA's Emergency Use Authorization may lead to increased international demand for Peramivir.

FDA's actions point to an emerging trend. H1N1 is leading to increased worry around the world. The World Health Organization, United States Government, and many other governments are looking for additional ways to treat the H1N1 virus. The FDA's Emergency Use Authorization of Peramivir illustrates that additoinal options are being brought to market. While the exact extent of the H1N1 Pandemic is not yet known, it is clear that the H1N1 pandemic will leave the world with increased medical knowledge.

References
Emergency use of antiviral IV medication for H1N1 Swine Flu symptoms approved by FDA. October 2009. Examiner.com. Retrieved on October 24, 2009 from http://www.examiner.com/x-18331-Natural-Health-Examiner~y2009m10d24-Emergency-use-of-antiviral-IV-medication-for-H1N1-Swine-Flu-symptoms-approved-by-FDA
Antiviral Treatment Options, including Intravenous Peramivir, for Treatment of Influenza in Hospitalized Patients for the 2009-2010 Season. October 2009. Centers for Disease Control. Retrieved on October 24, 2009 from http://www.cdc.gov/h1n1flu/EUA/peramivir_recommendations.htm