Baxter has been granted European regulatory approval for Vepacel, its new pre-pandemic influenza vaccine product.
The European Commission has granted marketing authorisation for the new drug in all EU member states, as well as Iceland, Liechtenstein and Norway, based on clinical studies involving more than 4,700 patients.
Vepacel is indicated for active immunisation of adults 18 years and older against the H5N1 subtype of influenza A, aka bird or avian flu, and has been created using proprietary advanced Vero cell technology from Baxter.
It offers cross-protection against a wide array of H5N1 strains and also offers a sustained immunological memory response, which will increase the efficacy of future booster vaccines.
Professor Hartmut Ehrlich, vice-president of global research and development in Baxter's bioscience business, said: "The approval of Vepacel demonstrates Baxter's commitment to the production of pandemic and pre-pandemic vaccines to protect vulnerable individuals from the H5N1 virus."
Last week, the company announced the commencement of a new phase III clinical study of a new stem cell-based therapy that offers potential benefits in the treatment of chronic myocardial ischemia.