Government and Regulations

FDA approves peramivir, first IV flu antiviral



Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*

It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.

“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.

“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,” he added.

Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.

“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.

Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.

The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.

*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.

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