ANDEMBRY® • Inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks. • Once-monthly dosing reduced HAE attacks by a median of more than 99% and a least squares mean of 89.2%, compared to placebo. ANDEMBRY® (garadacimab), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and paediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY® inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY®, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula. “ANDEMBRY®, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method. ANDEMBRY® underscores our longstanding and enduring commitment to better the lives of the patients we serve, including those suffering with HAE. I’d like to thank all the physicians, patients and my colleagues who contributed to this exciting milestone for HAE patients and CSL.” Bill Mezzanotte, MD, Executive Vice President, Head of R&D, CSL. HAE is a rare, chronic, and potentially life-threatening genetic disorder characterised by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group. Optimised launch excellence to outperform competition. Commercial During the period CSL Seqirus was recognised for its global leadership in pre-pandemic preparedness with the award of the vast majority of contracts for H5 avian flu. ANDEMBRY® Approved in the US, European Union (EU), United Kingdom (UK), Japan, Switzerland, Australia and the United Arab Emirates. The approval of ANDEMBRY® expands CSL’s HAE franchise and underscores the company’s legacy of delivering transformational innovations to the HAE community for over four decades. HEMGENIX® The first, one-time gene therapy treatment for adults with haemophilia B that offers long-term bleed protection, potentially eliminating the need for routine factor IX prophylaxis. HEMGENIX® was initially approved for use in the EU, UK, Canada, Switzerland and Australia and in FY2025, it was approved in Korea, Saudi Arabia, Hong Kong, Taiwan and Singapore. FILSPARI® In April 2025, the European Commission (EC) approved the conversion of the conditional marketing approval (CMA) for FILSPARI® into a standard marketing authorisation for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The EC’s decision is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal Phase III PROTECT study that demonstrated FILSPARI® significantly slowed kidney function decline over two years compared to irbesartan. The EC’s decision marks a significant milestone in providing a non-immunosuppressive treatment option for patients with IgAN. 9 CSL Limited Annual Report 2024/25
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