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BioCryst Announces Berotralstat Expanded Access Program for Patients with Hereditary Angioedema in United States
RESEARCH TRIANGLE PARK, N.C., June 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company has established
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., June 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company has established an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with hereditary angioedema (HAE) in the United States.\n 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 [email protected] 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). About BioCryst PharmaceuticalsBioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding future results, performance o...