Shionogi & Co has received a lightening fast approval in Japan to market the intravenous influenza drug, Rapiacta.
Rights to Rapiacta (peramivir) were licensed by Shionogi from the USA’s BioCryst Pharmaceuticals in Marck 2007, and the company has carried out Phase III studies on the antiviral in Japan, Taiwan and Korea. The Osaka-based company then filed a new drug application in November with the Japanese Ministry of Health, Labor and Welfare.
The agency granted a priority review and has acted extremely quickly in the wake of the swine flu outbreak, approving peramivir for single dose administration for uncomplicated seasonal influenza infection as well as single or multiple dose administration for adults at high-risk.
Shionogi added that it has also completed a clinical study in paediatric patients with uncomplicated seasonal influenza and “will make its best efforts to file an additional application” for that use of Rapiacta in the next few months.
The drug is a neuraminidase inhibitor like Roche’s oral Tamiflu (oseltamivir) and GlaxoSmithKline’s inhaled Relenza (zanamivir). It has been available in the USA since the government issued emergency use authorisation for Rapiacta in October 2009.
Shionogi said it believes Rapiacta “represents an important therapeutic advance for patients with influenza”. During “a fixed period following its launch”, the company will collect data on all patients who receive the drug “to keep healthcare professionals informed promptly of the proper use of the product”.
