BioCryst Pharmaceuticals, Inc. has established an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with HAE in the United States.
Through this program, physicians may be able to request berotralstat for HAE patients who do not have access to the product through a clinical trial.
According to the U.S. Food and Drug Administration (FDA), expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Requests for expanded access to berotralstat must be made by a U.S. licensed physician. Physicians can request access for a patient by sending an email to moc.autpecni@su.ssecca or calling 1-888-225-8677.
A new drug application for berotralstat is currently under review by the FDA with an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).
(Source: BioCryst)
