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news.BioCryst Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for RAPIVAB (peramivir injection), an intravenous (iv) neuraminidase inhibitor to treat acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
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The approval was based by data from over 2,700 subjects treated with peramivir in 27 clinical trials.
University of Alabama Dr Richard Whitley said: "RAPIVAB is the first neuraminidase inhibitor that has shown to be safe and effective as a single-dose, i.v. therapy for patients with acute, uncomplicated influenza, and represents the first new antiviral treatment for influenza approved by the FDA in 15 years.
"In a blinded, randomized placebo-controlled trial, a single dose of RAPIVAB alleviated flu symptoms, and reduced fever significantly faster than placebo."
So far, it is estimated that more than one million patients have received peramivir treatment.
BioCryst president and chief executive officer Jon Stonehouse said: "This is the first US approval of a BioCryst discovered drug and represents an important milestone for our company.
"We thank our funding partner BARDA/HHS; the development and approval of RAPIVAB is an excellent example of a successful public/private partnership."
The company said that rare cases of serious skin reactions, including Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB.