The FDA’s Office of Orphan Drug Development recently granted a seven-year exclusivity period to Valneva SE for Ixiaro, which was developed to prevent diseases caused by the Japanese encephalitis virus in children older than 2 months.
FDA will deny approval to any other vaccines that prevent JE in children throughout the exclusivity period, unless an alternative drug is found to be superior.
“We are very pleased that the FDA acknowledges the development and profile of Ixiaro and granted the seven years (of) market exclusivity,” Valneva President and CEO Thomas Lingelbach said.
The exclusivity period went into effect on May 17, which is the date that the FDA gave its approval to pediatric uses of Ixiaro.
The JE virus is transmitted by insects as well as animals like pigs and birds. Although transmission occurs after an infected mosquito or animal bites a human, most humans experience mild symptoms once infected with JE.
FDA grants orphan drug market exclusivity to prompt pharmaceutical companies to research and develop drugs and vaccines for niche markets like the JE virus. Ixiaro will be administered to fewer than 200,000 pediatric travelers to Asia each year, which is below the FDA’s maximum limit for exclusivity.
FDA also waives the $1 million fee to review submissions for a Biologics License Application to encourage niche drug development.