With the world's first pandemic in more than four decades covering the globe, BioCryst took another step toward FDA approval for its flu therapy peramivir with the announcement that two late-stage trials proved positive in Japan. Researchers say that intravenous peramivir was non-inferior to Tamiflu in both the 300 mg and 600 mg dose--hitting the primary endpoint.
Median time to alleviation of flu symptoms in all 37 evaluable patients treated with either 300 mg or 600 mg peramivir daily was 68.6 hours, according to the Birmingham, AL-based developer. Those results, reaped by BioCryst's Japanese partner Shionogi, help set the stage for late-stage trials designed to gain FDA approval.
"The clinical outcomes of these Phase III studies are important, especially during the declared influenza pandemic, as they indicate the promise of peramivir as a treatment for influenza," commented Dr. William P. Sheridan, the chief medical officer of BioCryst. "The need for additional anti-viral treatment options for influenza remains high. BioCryst is currently finalizing its plans for peramivir Phase III studies intended to support U.S. regulatory approval, while continuing to support the pre-emergency use authorization review of peramivir by the U.S. Food & Drug Administration."
- check out the press release
- check out the Reuters report