US FDA approves BioCryst's iv flu treatment
This article was originally published in Scrip
The US FDA has approved BioCryst Pharmaceuticals' flu treatment (peramivir injection) for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. The company plans to make it available for the 2014-15 flu season.
The neuraminidase inhibitor, which is BioCryst's first US approval, was developed there under a $234.8 million contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS). Peramivir already is approved Korea where is it marketed by Green Cross and in Japan where it is sold under the brand name Rapiacta by Shionogi.
Unlike the first two neuraminidase inhibitors, GSK's inhaled Relenza (zanamivir) and Roche's oral Tamiflu (oseltamivir), which are both dosed twice daily for five days, peramivir is delivered in one 600mg dose intravenously for 15 to 30 minutes, giving a new treatment option.
However, its US path to approval was temporarily blocked by a stop work order from the HHS in 2013, but a path forward for the product was found by the FDA (scripintelligence.com, 2 April 2013).