CSL Limited Annual Report 2021/22 35 New products to market CSL Behring continues to broaden the geography and use of our medicines for rare and specialty diseases across the globe within our immunology, haematology and vaccine therapeutic areas. Within the immunology portfolio, regulatory indication expansion and new registrations are primarily focused on our subcutaneous immunoglobulin HIZENTRA®, our intravenous immunoglobulin PRIVIGEN® and our human C1-esterase inhibitor BERINERT®. In 2021/22, indication expansion was sought for HIZENTRA® and PRIVIGEN® for chronic inflammatory demyelinating polyneuropathy (CIDP) and secondary immunodeficiency (SID). Additionally, further indication expansion for PRIVIGEN® was sought in select markets. CIDP is a chronically progressive, rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. 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. 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). Additionally, four new product registrations were achieved for RHOPHYLAC® 300 and two for TETAGAM®. In our haematology therapeutic area, the focus in 2021/22 was continuing the expansion of the current portfolio. Five new product registrations were achieved for our human coagulation factor VIII/vWF HAEMATE® and four for human albumin. Three new product registrations were achieved for each of BERIATE®, our human coagulation factor VIII product and AFSTYLA®, our recombinant factor VIII product, both of which are used to control and prevent bleeding episodes in people with haemophilia A, and three for BERIPLAST ® P, our combined human fibrinogen, factor XIII and bovine aprotinin product. Two new product registrations were achieved for HAEMOCOMPLETTAN® P, our human fibrinogen concentrate. Additionally, new product registrations were achieved for IDELVION®, our recombinant factor IX product, and BERIPLEX®, our human prothrombin complex concentrate. For our CSL Seqirus business, 2021/22 brought progress in the expansion of our influenza vaccine portfolio through new licences and extension of indications. In 2022, FLUAD® QUAD, our four-strain adjuvanted influenza vaccine, was authorised for persons 65 years and older in Argentina. Launch of FLUCELVAX® QUAD, for six months and above, was first achieved in Argentina in the Southern Hemisphere 2022 influenza season. FLUCELVAX® QUADRIVALENT was also approved for expanded age indications down to six months of age in the US. FLUCELVAX® QUAD was also approved for expanded age indications down to six months of age in Canada, down to two years of age in Australia and nine years in New Zealand. In Australia and New Zealand, CSL Seqirus’ in-licensing business continues to provide greater access to a broad portfolio of vaccines and medicines. The RYALTRIS® (olopatadine hydrochloride and mometasone furoate monohydrate) licence was extended in Australia to include the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients six years of age and older.
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