(Adnkronos) – ZURICH, Sept. 22, 2023 /PRNewswire/ — Takeda (TSE:4502) (NYSE:TAK) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lanadelumab (trade name TAKHZYRO®) 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.
HAE attacks, which can involve serious and severely debilitating swelling in the abdomen, face, feet, genitals, hands and throat, may occur very early in childhood. Potentially fatal upper airway angioedema has been reported in patients as young as 3 years old. HAE diagnosis can take an average of 8.4 years after symptom onset.2
"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," said Didier Relin, Head of International Regulatory at Takeda. "We know that HAE can be a complex, debilitating condition, and we are committed to being a champion for all individuals living with HAE." The positive opinion is supported by data from Phase 3 Study SHP643-301, also known as the SPRING study, a multicenter, open-label Phase 3 study to evaluate the safety profile and pharmacokinetics (PK) of lanadelumab in patients 2 to