FDA Approves the Intravenous Influenza Drug Peramivir

On December 22, 2014, the FDA announced the approval of peramivir (Rapivab) for treatment of uncomplicated influenza in adults who have been symptomatic for ≤2 days. The drug is the third neuraminidase inhibitor (NAI) to be approved for this indication but the first for intravenous use. It is administered as a single 600-mg infusion, with dose reductions in patients with renal dysfunction.

In a randomized, controlled trial involving 297 adults with uncomplicated influenza in Japan, a single 600-mg intravenous dose of peramivir decreased the time to symptom alleviation by 21 hours compared with placebo — comparable to what has been seen with oral oseltamivir and inhaled zanamivir. In a phase III study involving patients with uncomplicated influenza in South Korea, Japan, and Taiwan, peramivir proved noninferior to 5 days of oral oseltamivir.

Efficacy of peramivir could not be established, however, in patients with serious influenza requiring hospitalization. In a randomized, controlled, multicenter trial involving 398 such patients, 600 mg of peramivir administered daily for 5 days did not improve time to clinical resolution of symptoms compared with placebo. Patients in both study arms also received standard of care, which could include an oral or inhaled NAI.