FDA approves first IV flu medication

December 23, 2014

FDA approved the first intravenous influenza treatment, peramivir (Rapivab, BioCryst).

FDA approved the first intravenous influenza treatment, peramivir (Rapivab, BioCryst).

The single-dose flu medication is intended for adults with acute uncomplicated influenza, who are unable to swallow pills because of upper respiratory problems.

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Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. “Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows healthcare professionals and patients to have a choice based on an individual patient’s needs.”

Other neuraminidase inhibitors approved by FDA to treat flu include oseltamivir, administered orally, and zanamivir, which is inhaled. Older antiviral drugs for flu, amantadine and rimantadine, are no longer recommended by the Centers for Disease Control and Prevention (CDC) because circulating influenza strains are resistant to these drugs. 

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FDA said that Rapivab’s efficacy was established in 297 participants with confirmed influenza, who were randomly assigned to receive Rapivab 300 mg, Rapivab 600 mg, or a placebo. Overall, participants receiving Rapivab 600 mg. had their combined influenza symptoms alleviated 21 hours sooner on average than those receiving the placebo, which is consistent with other drugs in the same class.

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Those receiving Rapivab 600 mg also recovered to normal temperature approximately 12 hours sooner, compared to placebo. “However, efficacy could not be established in patients with serious influenza requiring hospitalization,” according to a statement from FDA.

Common side effects seen in Rapivab-treated participants include diarrhea. In addition, rare but serious side effects include serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme.