BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the US Food and Drug Administration (FDA) has approved Rapivab (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
"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. "In a blinded, randomized placebo-controlled trial, a single dose of Rapivab alleviated flu symptoms, and reduced fever significantly faster than placebo."
"The approval of Rapivab provides a new choice to immediately deliver an effective treatment in one dose to adult patients with influenza," said Jon P. Stonehouse, president & chief executive officer of BioCryst. "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."
Rapivab's approval was supported by 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 announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea under the name PeramiFlu. It is estimated that more than one million patients have received peramivir treatment to date. The recommended dose of Rapivab, in most adult patients 18 years of age or older with acute uncomplicated influenza, is a single 600 mg dose administered via intravenous infusion for 15 to 30 minutes. Rapivab was developed under contract number HHSO10020070032C from the Biomedical Advanced Research and Development Authority (BARDA/HHS), a $234.8 million contract.
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst 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.