CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE)

CSL announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks. The final European Commission (EC) decision is expected in Q1 2025.

Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, said: “CSL has a longstanding and relentless patient-focused approach to developing transformational medicines in areas of unmet need. This CHMP decision brings us closer to offering an innovative treatment to patients living with HAE, which is a debilitating and potentially life-threatening condition. We look forward to making this therapy available to patients in Europe.”

(Source: CSL)