CHMP recommends approval of Orladeyo in hereditary angioedema.- BioCryst Pharmaceuticals

BioCryst Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Orladeyo (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12?years and older. The European Commission (EC) will review the CHMP recommendation and a final approval decision from the EC on the marketing authorization application (MAA) for Orladeyo is expected in the second quarter.The CHMP positive opinion is based on data from the pivotal APeX-2 clinical trial and supporting data from the APeX-S trial. In APeX-2, Orladeyo met its primary endpoint (p<0.001) for orladeyo 150 mg compared to placebo. orladeyo showed a positive safety profile and was generally well-tolerated over 48 weeks in both apex-2 and apex-s.>