Since the first release of BioMedTracker’s H1N1 Influenza Pandemic Tracker report in early October, several material events have occurred involving vaccines and therapeutics for the pandemic influenza virus. Most notable are the approvals of 3 vaccines (one in the U.S. and two in Europe) and one anti-viral therapeutic (in the U.S.).

GlaxoSmithKline (GSK) recently gained approval for two vaccines targeting the influenza A pandemic virus. The first, FluLaval A(H1N1), was an sBLA to their approved, unadjuvanted, seasonal influenza vaccine, FluLaval. This supplemental approval joins four other, previously approved vaccines in the U.S. from Novartis, CSL Limited, Sanofi-Aventis and AstraZeneca.

GSK also received approval for its adjuvanted, mock-up vaccine, Pandemrix, in the E.U., joining several other marketed vaccines in Europe. Lastly, Novartis received approval for its adjuvanted, cell-based influenza vaccine, Celtura, in Germany.

Along with these vaccine approvals, one anti-viral treatment, intravenous peramivir by BioCryst, received an emergency use authorization (EUA) from the Food and Drug Administration (FDA) at the request of the Center for Disease Control (CDC). Peramivir joins the two most prevalent influenza anti-virals, Relenza (GSK) and Tamiflu (Roche, GILD, Chugai) as a means of reducing influenza symptoms once a patient contracts the A(H1N1) disease. Peramivir differentiates itself because it is the only anti-viral administered intravenously, and its EUA was granted so that patients who aren’t responsive to oral or inhaled therapies have another option.

October 09, 2009

Included in this report are vaccines and therapeutics involved in treating and preventing A(H1N1) influenza – both approved and still in development - organized into various categories. Along with a brief summarization of relevant news and information concerning the products in development, we have linked accompanying FDA and company press releases to provide further detail. BioMedTracker will continue to update this report as material events occur. For full report, please download the PDF version at the top of this page.

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