Posted by Michael Wonder on 26 Feb 2021
BioCryst receives positive CHMP opinion for Orladeyo (berotralstat), an oral, once daily therapy to prevent attacks in patients with hereditary angioedema
25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the approval of Orladeyo (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema in adult and adolescent patients aged 12 years and older.
The CHMP positive opinion is based on data from the pivotal APeX-2 clinical trial and supporting data from the APeX-S trial.
