CSL Ltd. — Regulatory Filings 2017

Sep 14, 2017

For immediate release 15 September 2017

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FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults

CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CSL Behring’s Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.

“The FDA approval of Privigen for CIDP represents a significant milestone for individuals with this debilitating and progressive disease. It is a testament to our commitment to meet the needs of patients with disabling neurologic conditions, including CIDP,” said Dr. Andrew Cuthbertson, chief scientific officer and director of Research and Development for CSL Limited. “As we focus on building a leading neurology franchise, we continue to advance clinical research to determine innovative and improved uses of immunoglobulin therapy that can benefit patients and improve their quality of life.”

For more information about Privigen, including the US Prescribing Information, visit www.privigen.com.

About CIDP

In CIDP, a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord), the myelin sheath, the protective covering of the nerves, is damaged. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP effects can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated. In the US, it is estimated that the incidence of CIDP is up to two patients per 100,000 people each year, with a prevalence of 40,000 people affected.

About Privigen®

Privigen is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIG stabilized with proline. A naturally occurring amino acid, proline has been shown to reduce IgG aggregation and dimer formation. Privigen has been approved to treat CIDP in Europe since 2013. In the US, Privigen is also approved for primary humoral

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15 September 2017

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immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older. It is available in over 70 countries around the world for treating these and other rare diseases.

About CSL

CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 60 countries and employs nearly 20,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

For further information, please contact:

Investors:

Media:

Mark Dehring Jemimah Pentland VP, Investor Relations Head of Asia Pacific Communications CSL Limited CSL Limited T: +613 9389 3407 T: +613 9389 3473 M: +61 412 635 483 Email: mark.dehring@csl.com.au Email: jemimah.pentland@csl.com.au

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