Peramivir earns FDA approval to ease flu symptoms in adults
Peramivir earns FDA approval to ease influenza symptoms in adults
HealthDay News – Peramivir (Rapivah) has been approved by the United States Food and Drug Administration (FDA) to treat influenza in adults.
The intravenous drug inhibits neuraminidase, an enzyme that releases viral particles from infected cells, the FDA explained in a news release.
Peramivir is approved for patients aged 18 years and older, with acute uncomplicated influenza, who have had flu symptoms for no more than two days. It is administered as a single intravenous dose.
The drug's safety and effectiveness were evaluated in a randomized clinical study of 297 patients with a confirmed case of the flu. Those given the newly approved drug had symptoms ease about 21 hours sooner compared with people who didn't take the drug, the FDA said.
Common side effects include diarrhea; rare, but serious, side effects include serious skin or hypersensitivity reactions. The agency stressed that peramivir and other antiviral drugs are not substitutes for getting the annual flu vaccine.
"[Peramivir] is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an intravenous formulation," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release.
"The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health-care professionals and patients to have a choice based on an individual patient's needs."