SRPT - BioCryst Berotralstat PDUFA And Other News: The Good Bad And Ugly Of Biopharma
BioCryst Pharmaceuticals Goes Ahead with Expanded Access Program for Berotralstat
BioCryst Pharmaceuticals Inc. (BCRX) announced launching its Expanded Access Program for berotralstat. The program will allow physicians to request the drug for hereditary angioedema patients who do not have access to the product through a clinical trial. BioCryst has filed an application with the FDA for berotralstat. The PDUFA date has been set at December 3, 2020.
As per the FDA, expanded access program is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain