The multi-centred, placebo controlled study measured the prophylactic effect of the two dosage regimes against influenza infection against placebo and the protective efficacy calculated.
Compared to placebo, Inavir in two dose regimes significantly reduced the proportion of patients contracting influenza (p < 0.0001) and produced protective efficacies in excess of 70%.
Biota CEO Peter Cook said approval in the new indication will expand the market applicability for Inavir and further solidify its role in pandemic control.
"We continue to believe that Inavir’s demonstrated efficacy, combined with its ease of use, have the opportunity to significantly improve clinical outcomes for the treatment and now prevention, of influenza," Cook added.
According to the study data, Inavir was generally well tolerated and its safety profile remained consistent with that seen previously in the clinical development program.