BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for a pediatric indication of RAPIVAB (peramivir injection), which was submitted in March 2017. The sNDA has been classified by the FDA as a priority review and has a Prescription Drug User Fee Act (PDUFA) goal date for a decision by the end of September 2017.
“The acceptance of the pediatric sNDA by the FDA represents another important milestone for BioCryst and our partner, Seqirus,” said Jon P. Stonehouse, President & Chief Executive Officer. “We are excited the FDA has granted a priority review with the possibility of making RAPIVAB available to treat pediatric patients in the next flu season.”
RAPIVAB is being commercialized by Seqirus globally, excluding Japan, Taiwan, Korea and Israel. Seqirus is a leader in influenza prevention through the global supply of seasonal and pandemic influenza vaccines.
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.