FDA Approves Biocryst Pharmaceuticals's Intravenous Flu Drug Rapivab

FDA Approves Biocryst Pharmaceuticals's Intravenous Flu Drug Rapivab
December 22, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

North Carolina biotech BioCryst Pharmaceuticals, Inc. said Monday that the U.S. Food and Drug Administration has approved its intravenous flu treatment Rapivab for patients with acute uncomplicated influenza who are 18 years and older and have been symptomatic for no more than two days.

Rapivab (peramivir injection) is an intravenous neuraminidase inhibitor that in a blinded, randomized placebo-controlled trial, showed only a single dose alleviated flu symptoms and reduced fever significantly faster than a placebo.

"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," said Richard Whitley, M.D., University of Alabama at Birmingham.

BioCryst is focused on the development and commercialization of treatments for rare and infectious diseases. It currently has several ongoing development programs: oral inhibitors of plasma kallikrein for hereditary angioedema, including BCX4161 and several second generation compounds; and BCX4430, a broad spectrum viral RNA polymerase inhibitor.

The drug’s recent approval was made after the FDA reviewed data from over 2,700 subjects treated with peramivir in 27 clinical trials. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name Rapiacta and in August 2010, Green Cross Corporation said it would test the drug in Korea under the name PeramiFlu.

BioCryst said so far around one million patients have received peramivir, with the recommended dose a single 600 mg amount administered via intravenous infusion for 15 to 30 minutes. The drug was developed under contract number HHSO10020070032C from the Biomedical Advanced Research and Development Authority, a $234.8 million contract.

"The approval of Rapivab provides a new choice to immediately deliver an effective treatment in one dose to adult patients with influenza," said Jon Stonehouse, president and chief executive officer of BioCryst, in a statement. "This is the first U.S. 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."

Back to news