CSLLY - CSL gets FDA approval for Hizentra 50mL prefilled syringe

2023-04-19 05:38:55 ET

• CSL Behring said on Tuesday that the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid).
• CSL Behring, a unit of Australia's CSL ( OTCPK:CSLLY ) ( OTCPK:CMXHF ), now offers a range of prefilled syringe sizes for people with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• People with PI have an immune system which does not work correctly which leads to frequent infections. There are more than 400 types of PI. Meanwhile, CIDP is a neurological disorder in which there is progressive weakness and reduced senses in the arms and legs. The condition affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves called myelin sheath.
• Hizentra is the first and only immune globulin (Ig) available in a simple and ready-to-use prefilled syringe, according to the company.
• "Having prefilled syringes available that allow people with conditions such as CIDP to administer their treatment at home, on their schedule, can help decrease treatment burden," said Lisa Butler, executive director, GBS|CIDP Foundation.

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