MedImmune's FluMist sBLA makes progress
US cancer and infectious and inflammatory diseases specialist MedImmune says that the Food and Drug Administration has completed its review of documents relating to a supplemental Biologics License Application for its influenza vaccine, FluMist. The sBLA is seeking an expansion to the age range for which the product is approved.
MedImmune also reported that the FDA has agreed on both revised labeling for the product, as well as the protocol to be used in planned post-marketing studies. The firm added, however, that the FDA would not make its final approval decision until compliance issues arising from a recent inspection of its UK bulk manufacturing plant are satisfactorily resolved.
The firm, which is currently the subject of a $15.6 billion takeover bid from Anglo-Swedish drugmaker AstraZeneca (Marketletter April 30), said that it was pleased with the progress that its sBLA had made and added that it was working diligently to correct the concerns raised regarding its UK plant. The company added that it plans to manufacture the recently approved cold-storage formulation of the product for the 2007-2008 influenza season.
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