The Food and Drug Administration (FDA) has expanded the approval of Rapivab® (peramivir injection; BioCryst) to include treatment of acute uncomplicated influenza in patients 6 months of age and older who have been symptomatic for no more than 2 days. Previously, the treatment was indicated for patients aged 2 years and older.
The expanded approval was based on data from a multicenter, randomized, open-label, active-controlled trial. The trial evaluated the efficacy and safety of peramivir, an influenza virus neuraminidase inhibitor, in patients 6 months to 17 years of age with acute uncomplicated influenza who had a fever greater than or equal to 37.8°C with at least 1 respiratory symptom or a positive influenza rapid antigen test. Patients were randomly assigned to receive a single intravenous dose of peramivir 600mg (13 to 17 years of age) or 12mg/kg up to a maximum dose of 600mg (6 months to 12 years of age), or oral oseltamivir twice a day for 5 days.
In the peramivir arm, the median time to alleviation of combined influenza symptoms was 79 hours (interquartile range: 31-126 hours) compared with 100 hours (interquartile range: 57-145 hours) in the oseltamivir arm. The median time to recovery to normal temperature (less than 37°C) was 40 hours (interquartile range: 21-68 hours) with peramivir and 35 hours (interquartile range: 16-42 hours) with oseltamivir.
“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,” said Dr William Sheridan, chief medical officer of BioCryst. “These patients can be among those at greatest risk for severe outcomes and Rapivab is an important antiviral with proven benefits.”
Rapivab is supplied in single-use vials containing 10mg/mL strength solution for intravenous infusion following dilution.
- BioCryst announces FDA approval of supplemental New Drug Application for Rapivab® expanding patient population to include children six months and older. [press release]. Research Triangle Park, NC: BioCryst Pharmaceuticals, Inc.; February 3, 2021.
- Rapivab® [package insert]. Research Triangle Park, NC: BioCryst Pharmaceuticals, Inc.; 2021.