Takeda receives CHMP opinion recommending approval of lanadelumab for prevention of HAE attacks in patients aged 2 years and older

Takeda receives CHMP opinion recommending approval of lanadelumab for prevention of HAE attacks in patients aged 2 years and older

Takeda today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lanadelumab for the routine prevention of Hereditary Angioedema (HAE) in patients aged 2 years and older. If approved, lanadelumab will be the first long-term prophylactic treatment available in the EU for patients under the age of six. The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months. Lanadelumab is currently indicated for the routine prevention of recurrent attacks of HAE in patients aged 12 years and older.

Didier Relin, Head of International Regulatory at Takeda, said: “We are so pleased to achieve this positive step towards providing the first long-term prophylactic treatment option to prevent attacks in this vulnerable population. We know that HAE can be a complex, debilitating condition, and we are committed to being a champion for all individuals living with HAE.”

(Source: Takeda Pharmaceuticals)