FDA Approves First One-Dose IV Drug for Influenza

FDA Approves First One-Dose IV Drug for Influenza
FDA Approves First One-Dose IV Drug for Influenza

BioCryst announced that the Food and Drug Administration (FDA) has approved Rapivab (peramivir) injection for the treatment of acute uncomplicated influenza in patients ≥18 years who have been symptomatic for no more than two days.

Rapivab is the first single-dose, intravenous (IV) neuraminidase inhibitor for acute uncomplicated influenza. It inhibits an enzyme that releases viral particles from the plasma membrane of infected cells. Its antiviral activity against laboratory strains and clinical influenza virus isolates was determined in cell culture.

RELATED: Single-Dose, Injected Flu Treatment Shows Promise

The FDA approval is based on data from 27 clinical trials evaluating over 2,700 patients treated with peramivir. Study results from a blinded, randomized, placebo-controlled trial showed that a single dose of Rapivab relieved flu symptoms and reduced fever significantly faster when compared to placebo.

Rapivab injection is available to order as 200mg/20mL (10mg/mL) strength single-dose vials in 3-count cartons.

For more information call (844) 727-4822 or visit Rapivab.com.

Loading links....