CSL Ltd Annual Report 2020

New products to market CSL Behring continues to broaden the geography and use of our medicines for rare and speciality diseases across the globe within our Immunology and Haematology therapeutic areas. Within the immunology portfolio, regulatory indication expansion and new registrations are primarily focused on our subcutaneous immunoglobulin, HIZENTRA, and our intravenous immunoglobulin, PRIVIGEN. In 2019/20, indication expansion was sought for HIZENTRA for chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) 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. MMN is a rare, progressive neuropathy that presents as muscle weakness asymmetrically in the extremities. Notably, in February 2020, PRIVIGEN was approved for primary immunodeficiency (PI) and secondary immunodeficiency (SI) by Japan’s Ministry of Health, Labour and Welfare (MHLW). Additionally, four new product registrations were achieved for each of HIZENTRA and PRIVIGEN and five for ALBUREX ® /ALBUMINAR ® . In our haematology therapeutic area, the focus in 2019/20 was expansion of the current portfolio. Six new product registrations were achieved for our recombinant FVIII product, AFSTYLA, three new product registrations for IDELVION, our recombinant FIX product, seven for BERIATE ® , our factor FVIII product, three for our prothrombin complex, BERIPLEX ® , plus additional approvals for HAEMOCOMPLETTAN ® and CORIFACT ® /FIBROGAMMIN ® (refer to Product Registrations and Indications 2019/20). Additionally in May 2020, IDELVION received a favourable opinion from the European Committee for Medicinal Products for Human Use (CHMP) on updated product labelling that included a description of 21-day expanded dosing schedule. For Seqirus, 2019/20 brought significant progress in broadening our influenza vaccine portfolio. In 2019, Seqirus achieved marketing approval in Australia for FLUAD ® QUAD, indicated for protection of adults 65 years and older against seasonal influenza. This was the first of a number of approvals during the period for the adjuvanted quadrivalent influenza vaccine, which included licensure in Europe (as FLUAD ® TETRA) and the US (as FLUAD ® QUADRIVALENT). We continue to expand the availability of our four-strain influenza vaccine, AFLURIA ® QUAD, the egg-based vaccine manufactured at our Parkville, Australia plant. AFLURIA ® QUAD was granted approval in Argentina and New Zealand in 2019 and South Korea, Germany and Austria (as AFLURIA ® TETRA) in 2020, while AFLURIA ® QUAD JUNIOR was registered in New Zealand for ages six months to three years in 2019. The global rollout of FLUCELVAX ® QUAD continued, with approval in Canada for people aged nine years and above in 2019, in Taiwan for people aged three years and above in 2020, and in Brazil for two years and older (as FLUCELVAX ® TETRA). In 2020, FDA approval was granted for AUDENZ, an adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic. This vaccine enables the potential for rapid deployment in the event of an H5N1 pandemic emergency. AUDENZ™ is indicated for people six months and above. In Australia and New Zealand, Seqirus’ in-licensing business helps provide greater access to a broad portfolio of vaccines and medicines. The Australian allergy portfolio was reinforced with the approval in 2019 of RYALTRIS ® nasal spray for treatment of symptoms of allergic rhinitis and rhino-conjunctivitis. CATIONORM ® , an ophthalmic treatment for dry eyes, was the first product for an eye-care portfolio when Australian registration was granted in 2019. 29 product registrations or new indications for serious diseases. , Until she turned 40, Stacy Ahearn spent a life powering through illnesses to pursue her passion for fitness. Stacy ran marathons and even met the challenge of the legendary Ironman Triathlon. When repeated illnesses forced Stacy to put her athletic career on hold, she began to seek a diagnosis. After years of tests, she was finally diagnosed with common variable immune deficiency, one of more than 200 primary immune deficiency conditions. After getting the treatment she needs, Stacy is again chasing her dreams. She recently hit the trail to conquer the famed Camelback Mountain near her Arizona, US, home. Stacy Ahearn CSL Limited Annual Report 2020 28 Powered by Innovation 7