CSL Limited Annual Report 2022/23 14 CSL Vifor Iron deficiency and nephrological disorders pose significant unmet medical needs globally. The CSL Vifor portfolio provides a strong and rapidly growing presence in nephrology, particularly in patients requiring dialysis. CSL Vifor is committed to launching the next generation of therapies as it endeavours to truly address the full spectrum of kidney disease, with a focus on dialysis and rare disease. This is supported by a founding heritage and expertise in iron deficiency therapy, helping to support a broad range of patients. The acquisition of Vifor Pharma in August 2022 has enhanced CSL’s product portfolio, complementing existing products and offering a wider range of treatments for conditions such as chronic kidney disease (CKD), anaemia and renal disorders. Key CSL Vifor products on the market include TAVNEOS®, KORSUVA®/ KAPRUVIA®, MIRCERA®, RETACRIT®, VELTASSA®, RAYALDEE®, VELPHORO® and our iron products FERINJECT®/INJECTAFER®, VENOFER® and MALTOFER®. With the combination of resources, research capabilities, scientific insights and CSL’s patient-centred approach, CSL can develop innovative therapies, accelerate the development of novel treatments, improve patient outcomes, and contribute to advancements in these specialised fields. This expanded portfolio positions CSL to address a wider range of unmet needs in patients with iron and nephrological disorders and should support a more comprehensive range of options for patients with improved access to effective treatments leading to better disease management, enhanced quality of life and improved patient care overall. In June, we initiated further activities to progress the integration of the CSL Vifor R&D teams and programs into the overall CSL R&D organisation and processes. This includes incorporating them into our Therapeutic Areas and Project Operating Model, as well as aligning themwith our R&D governance framework. More information about the CSL Vifor R&D integration will be communicated at our annual R&D update to the market. New products to market CSL continues to broaden the geography and use of its medicines for rare and specialty diseases across the globe within the immunology and haematology therapeutic areas as well as in nephrology and iron deficiencies, and the use of vaccines to help prevent infectious disease and protect public health. Within the immunology portfolio, regulatory indication expansion and new registrations are primarily focused on subcutaneous immunoglobulin, HIZENTRA®, and our human C1-esterase inhibitor, BERINERT®, each with four new registrations including, importantly, BERINERT® S.C. Injection 2000 in Japan for the treatment of HAE. The new HIZENTRA® registrations supported indications for primary immunodeficiency (PID), a chronic disorder in which part of the body’s immune system is missing or malfunctioning, and chronic inflammatory demyelinating polyneuropathy (CIDP), a chronically progressive, rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. With CIDP, the myelin sheath, or the protective covering of the nerves, is damaged, which may result in numbness or tingling, muscle weakness, fatigue and other symptoms, which worsen over time. Additionally, indication expansion was approved for HIZENTRA® for secondary immunodeficiency (SID) in two countries. SID is similar to primary immunodeficiency (PID); however, SID occurs when the immune system is compromised as a result of disease or due to an environmental factor (e.g., chemotherapy, disease complication). In CSL’s haematology therapeutic area, there is continued focus on the expansion of the current portfolio as well as the first registrations of HEMGENIX®, etranacogene dezaparvovec, a one-time gene therapy for the treatment of adults with haemophilia B. Five new registrations were achieved for our recombinant factor VIII product, AFSTYLA®, which is used to control and prevent bleeding episodes in people with haemophilia A. Four new registrations were achieved for our human coagulation factor VIII/vWF, HAEMATE® and seven for human albumin. One new registration was achieved for BERIPLEX®, our human prothrombin complex concentrate and one for BERIPLAST® P, our combined human fibrinogen, factor XIII and bovine aprotinin product. Four new registrations were achieved for HAEMOCOMPLETTAN® P, our human fibrinogen concentrate. Three new registrations and expansions were achieved for IDELVION®, our recombinant factor IX albumin fusion protein (rFIX-FP) which is used to control and prevent bleeding episodes in people with haemophilia B. For our CSL Seqirus business, FLUAD® QUADRIVALENT, our adjuvanted influenza vaccine, was authorised for persons 65 years and older in Taiwan, Brazil and South Korea. For CSL Vifor, there were seven new registrations for KORSUVA® (difelikefalin), for the treatment of moderate-tosevere pruritus associated with chronic kidney disease in adult patients on haemodialysis. Four new registrations were achieved for TAVNEOS® (avacopan) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)- associated vasculitis. For VELPHORO®, there were two new registrations for the control of serum phosphorus levels in adults with chronic kidney disease on haemodialysis or peritoneal dialysis. There was one new registration for VELTASSA® (patiromer sorbitex calcium) for the treatment of high blood potassium. There was one new registration, and two label expansions for FERINJECT® (ferric carboxymaltose) and one indication expansion for INJECTAFER®, ferric carboxymaltose injection, for the treatment of iron deficiency in patients with heart failure. 2 Our Company
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