European CHMP recommends approval of berotralstat (Orladeyo) for prevention of recurrent attacks of hereditary angioedema (HAE)

Berotralstat is an oral inhibitor of plasma kallikrein which acts by reducing the release of bradykinin, a potent vasodilator involved in HAE attacks. In clinical trials, HAE attacks were reduced by 44% vs placebo in adult and adolescent patients aged 12 years and older.

Source:

European Medicines Agency