ORLADEYO
™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
The full European Summary of Product Characteristics (SMPC) for ORLADEYO will be available from the European Medicines Association website at
About BioCryst Pharmaceuticals
BioCryst 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. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States, European Union and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the United Kingdom. BioCryst has several ongoing development program
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Early Access to BioCryst’s Berotralstat Granted for HAE Patients in France
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RESEARCH TRIANGLE PARK, N.C., March 11, 2021 (GLOBE NEWSWIRE) BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the French National Agency for Medicines and Health Products Safety (ANSM) has granted an Autorisation Temporaire d Utilisation de cohorte (cohort ATU), or Temporary Authorization for Use, for the use of berotralstat to prevent attacks of hereditary angioedema (HAE) in appropriate patients aged 12 and older.
This cohort ATU allows patients with HAE in France to receive treatment with berotralstat before the drug is granted marketing authorization by the European Commmission (EC).
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