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Peramivir Injection Shows Promise Against Influenza

FDA approval decision expected in December

Positive trial results related to peramivir injection (Rapivab, BioCryst Pharmaceuticals), a neuraminidase inhibitor for the treatment of influenza, have been presented at the Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC), held September 5&ndash9 in Washington, D.C.

Single-dose intramuscular (IM) peramivir was generally safe and well tolerated, and reduced the duration of clinical symptoms and viral shedding in patients with acute uncomplicated influenza. The median time to the alleviation of influenza symptoms after treatment with peramivir 300 mg was 113.2 hours compared with 134.8 hours with placebo (P = 0.161 adjusted for smoking behavior, influenza season, and virus type; and P = 0.047 unadjusted).

The median time to the resolution of fever was reduced by 24.0 hours after treatment with peramivir 300 mg compared with placebo (P = 0.004). Moreover, influenza viral shedding was significantly decreased during the first 48 hours after peramivir treatment (P = 0.009), and the detection of post-treatment viruses with decreased susceptibility to NAIs was rare. The size of the treatment effect was similar to that reported for other NAIs.

In another presentation, exposures to peramivir dosed by either intravenous (IV) infusion or IM injection were shown to be equivalent.

In December 2013, a new drug application (NDA) was submitted to the FDA seeking an indication as the first IV neuraminidase inhibitor approved in the U.S. The NDA is currently under regulatory review, with a Prescription Drug User Fee Act (PDUFA) data of December 23, 2014. If approved, peramivir would be marketed as Rapivab (peramivir injection).

Peramivir is an investigational IV antiviral agent that rapidly delivers high plasma concentrations to the sites of infection. The drug inhibits the interactions of influenza neuraminidase, an enzyme that is critical to the spread of influenza within the host. Peramivir is an inhibitor of influenza A and B viruses, including H7N9 and pandemic H1N1 swine flu viral strains.

In January 2010, peramivir was launched in Japan under the trade name Rapiacta to treat patients with influenza, and in August 2010, marketing and manufacturing authorization was granted to peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For patients with uncomplicated influenza outside Japan and Korea, the only approved antivirals are oral or inhaled formulations.

According to the Centers for Disease Control and Prevention (CDC), an estimated 5% to 20% of the American population develops influenza annually, and approximately 3,000 to 49,000 flu-related deaths occur per year in the U.S. The people at greatest risk are young children, the elderly, and those with seriously compromised immune systems.

Sources: BioCryst Pharmaceuticals; September 6, 2014; and Peramivir; 2014.

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