Posted by Michael Wonder on 03 May 2021
BioCryst receives European Commission approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
30 April 2021 - BioCryst Pharmaceuticals today announced that the European Commission has approved oral, once daily Orladeyo (berotralstat) for the prevention of recurrent hereditary angioedema attacks in hereditary angioedema patients 12 years and older.
In the United Kingdom, HAE patients also currently have access to Orladeyo through an approved early access to medicines scheme. A marketing authorisation application has been submitted to the MHRA. Under the new European Commission Decision Reliance Procedure, the MHRA will aim to complete the review of the UK marketing authorisation application as soon as possible following the European Commission approval decision.
