FDA OKs Expanded Use of Peramivir Injection in Younger Patients With Influenza
Peramivir injection (Rapivab; BioCryst) is approved for use in patients aged 6 months and older.
Officials with the FDA have approved a supplemental new drug application for peramivir injection (Rapivab; BioCryst) to expand the patient population to include those aged 6 months and older.1
Peramivir injection is indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 2 days. It is administered via an intravenous (IV) infusion for a minimum of 15 minutes at recommended doses of 600 mg/kg for adults and adolescents and 12 mg/kg for pediatric patients aged 6 months to 12 years.
“Influenza can have serious and deadly consequences and we are very pleased that the FDA has extended the approved indication for Rapivab to include patients as young as 6 months,” William Sheridan, MB BS, chief medical officer of BioCryst, said in a statement. “These patients can be among those at greatest risk for severe outcomes and Rapivab is an important antiviral with proven benefits.”
The efficacy of peramivir injection is based on clinical trials of naturally occurring influenza, in which the predominant infections were influenza A virus and a limited number of patients infected with influenza B virus.
According to the CDC, seasonal influenza activity in the United States remains lower than usual for this time of year. Preliminary data show 142 laboratory-confirmed influenza hospitalizations so far this season. And while 14.8% of deaths for the week ending January 23, 2021, were attributed to pneumonia, influenza, or coronavirus disease 2019 (COVID-19) (PIC), the majority of PIC deaths are due to COVID-19. One influenza-associated pediatric death has been reported to the CDC for this season.2
References
- BioCryst Announces FDA Approval of Supplemental New Drug Application for RAPIVAB Expanding Patient Population to Include Children 6 Months and Older. News release. BioCryst; February 3, 2021. Accessed February 4, 2021. https://ir.biocryst.com/news-releases/news-release-details/biocryst-announces-fda-approval-supplemental-new-drug.
- CDC. Weekly US Influenza Surveillance Report. Last updated January 29, 2021. Accessed February 4, 2021. www.cdc.gov/flu/weekly/index.htm#S2
