FDA approves Rapivab for treatment of influenza in adults

The FDA has approved the IV drug peramivir for the treatment of influenza in adults, according to a press release.

Peramivir (Rapivab, BioCryst Pharmaceuticals), a neuraminidase inhibitor, is indicated for patients aged 18 years or older with acute uncomplicated influenza who have been symptomatic for no more than 2 days.

Rapivab is the most recent influenza treatment approved by the FDA, but the first neuraminidase inhibitor administered intravenously. Other antiviral treatments recommended by the CDC include oseltamivir (Tamiflu, Roche), which is administered orally, and zanamivir (Relenza, GlaxoSmithKline), which is inhaled.

“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,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in a press release.

Edward Cox

Rapivab’s efficacy was evaluated in 297 participants with confirmed influenza randomly assigned 300 mg Rapivab, 600 mg Rapivab or placebo. Those who received the 600-mg dosage had their symptoms alleviated an average of 21 hours sooner than those who received placebo; normal temperature also occurred about 12 hours sooner. Additional trials supported these findings, but efficacy was not determined in patients hospitalized due to influenza.

The most common adverse effect associated with peramivir was diarrhea. Reports of serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme were rare.

Rapivab, along with other antiviral influenza treatments, is not a replacement for the annual influenza vaccination recommended by the CDC’s Advisory Committee on Immunization Practices.