Rapivab (peramivir) filed with EMA for influenza in adults 18 years and older- BioCryst Pharma

BioCryst Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted the filing of its Rapivab (peramivir) Marketing Authorization Application (MAA) for treatment of symptoms typical of influenza in adults 18 years and older. The acceptance of the MAA begins the review process by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland. Peramivir’s efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.

Efficacy of peramivir is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled. The efficacy of peramivir could not be established in patients with serious influenza requiring hospitalization. In clinical studies, side effects with peramivir were similar to placebo. The most common adverse reaction was diarrhea (peramivir 8% vs 7% placebo).