Swissmedic approves CSL Behring’s Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema (HAE)

CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to Andembry (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Andembry, a monoclonal antibody, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body.

Emmanuelle Lecomte-Brisset, Global Head of Regulatory Affairs at CSL, said: “This approval from Swissmedic marks the fifth regulatory approval of Andembry for HAE, following recent approvals in Australia, the UK, the EU, and Japan. We are incredibly proud of these milestones, which reflect our decades-long commitment to delivering innovative medicines to the HAE community. Access and reimbursement negotiations are currently underway to ensure that Andembry is made available to eligible people with HAE in Switzerland.”

Dr Isabelle Dahinden, General Manager Switzerland, CSL Behring, said: “With the approval of Andembry, following Berinert IV (intravenous) and Berinert SC (subcutaneous), CSL Behring now offers an even more comprehensive portfolio for the management of HAE. This allows us to meet the diverse needs of people living with HAE, a community we have supported for more than 40 years.”

Dr Michael Haslauer, Country Medical Lead Switzerland, CSL Behring, said: “While there are current treatments available for HAE, individual needs and responses to treatment vary. Andembry offers people living with HAE a vital new treatment option that provides long-term control over their disease.”

(Source: CSL)