moksha8 and BioCryst today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) antiviral that is currently available under an Emergency Use Authorization in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.
"Rapidly bringing important novel products to patients in need in Mexico and Brazil is core to our vision," said Ayse Kocak, Head of moksha8 in Mexico. "The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government's commitment to public health. We look forward to bringing this potentially life saving drug to as many patients as possible."
"We are pleased that the Mexican government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "The relationship between BioCryst and moksha8, established only three months ago, is producing the near-term results we desired. We are prepared to respond to any peramivir order we may receive under this authorization from Mexico."