Benzinga | Feb 3, 2021 07:01AM EST

BioCryst Announces FDA Approval of Supplemental New Drug Application for RAPIVAB Expanding Patient Population to Include Children Six Months and Older

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for RAPIVAB(r) (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.

"Influenza can have serious and deadly consequences and we are very pleased that the FDA has extended the approved indication for RAPIVAB to include patients as young as six months. These patients can be among those at greatest risk for severe outcomes and RAPIVAB is an important antiviral with proven benefits," said Dr. William Sheridan, chief medical officer of BioCryst.