CSL Ltd Annual Report 2019

15 Seqirus proudly stands on the front-line of influenza protection, supplying vaccines to public health partners around the world to prevent influenza and protect against pandemic threats. Our focus is on improving the effectiveness of our current influenza vaccines while working on longer-term transformational approaches to influenza protection. Adjuvanted vaccines Influenza Science Quadrivalent vaccines Cell-based Egg-based New products to market During the reporting year, we achieved 24 product registrations or new indications for serious diseases. Strong progress was made in CSL Behring’s immunology and neurology portfolio over the past year. In March 2019, Japan’s Ministry of Health, Labour and Welfare approved two of CSL’s immunoglobulin therapies for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). 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. HIZENTRA ® , previously approved to treat primary immunodeficiency (PI), is now the first and only subcutaneous immunoglobulin approved for maintenance therapy to treat CIDP in Japan. PRIVIGEN ® , our intravenous immunoglobulin, is now approved for both acute and maintenance therapy of CIDP in Japan. In April 2019, CSL Behring gained US Food and Drug Administration (FDA) approval of convenient single-vial dosing for ZEMAIRA ® , Alpha1-Proteinase Inhibitor (Human). Alpha 1 antitrypsin (AAT) deficiency is a hereditary condition that can severely affect a patient’s lung function. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of AAT is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy. Once commercially launched, the new vial options deliver on CSL’s heritage of innovation by providing more alternatives to patients and streamlining their current treatment regimen. For Seqirus, in December 2018, marketing approval from the European Commission for its cell-based seasonal influenza vaccine, FLUCELVAX ® TETRA was achieved. This is the first cell-based quadrivalent influenza vaccine available in Europe. Cell-based technology represents one of the most significant advances in the way influenza vaccines are manufactured since the 1940s. Cell-based technology avoids egg-adapted changes associated with traditional manufacturing methods and may therefore offer a closer match to circulating viruses than traditional egg-based influenza vaccines. In October 2018, an expanded age indication for AFLURIA ® QUADRIVALENT (influenza vaccine) for use in people six months of age and older was approved in the United States (US). This approval also applied to the trivalent formulation of AFLURIA ® (influenza vaccine). In February 2019, AFLURIA ® QUAD (influenza vaccine) was also granted an expanded indication for use in people six months of age and older in Australia, extending Seqirus’ influenza vaccine offerings. In the reporting period, Seqirus supplied 10 million doses of FLUAD for the entire 65 years and above population in the United Kingdom (UK), in the 2018/19 northern hemisphere season. Following registration approval last year, RAPIVAB ® , an intravenous antiviral treatment for influenza was launched in Australia in June 2019, expanding our influenza portfolio in this market. In Australia and New Zealand, Seqirus’ in-licensing business helps provide greater access to a broad portfolio of vaccines and medicines. The Australian neurology portfolio was strengthened with the approval in October 2018 and subsequent listing of two new products, TEGLUTIK ® for treatment of patients with amyotrophic lateral sclerosis (ALS) and XADAGO™ for Parkinson’s disease. CSL Limited Annual Report 2019 16 Powered by Innovation 24 product registrations or new indications for serious diseases.