Shionogi receives expanded approval for pediatric use of i.v. peramivir in Japan

Oct 27 2010

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that its partner, Shionogi & Co., Ltd. has received approval for an additional indication for use of intravenous (i.v.) peramivir to treat children and infants with influenza in Japan. In January 2010, Shionogi received the world's first approval for i.v. peramivir and launched it under the commercial name RAPIACTA^® in Japan. It was initially approved for the treatment of adults with uncomplicated seasonal influenza, as well as those at high-risk for complications associated with influenza.

"We congratulate Shionogi on receiving the expanded approval for pediatric use of i.v. peramivir in Japan. Parents and medical practitioners in Japan desire an additional option to treat pediatric influenza infections, as children with influenza can be at risk of severe symptoms and complications," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "BioCryst is currently advancing its Phase 3 i.v. peramivir studies toward completion, with the goal of regulatory filing for approval in the U.S."

Shionogi has stated it intends to secure an adequate supply of RAPIACTA^® to treat approximately 1,000,000 people during the upcoming influenza season. In addition, Shionogi is taking steps to ensure its manufacturing capability and a stable supply to meet urgent demands.