The US Food and Drug Administration (FDA) has approved CSL Behring’s Hizentra, the first and only subcutaneous immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
This approval comes just a day after the company, a subsidiary of Australia's CSL Limited (ASX: CSL), received approval to sell Hizentra in Europe in the same indication.
CIDP, more commonly known as Vidaurri’s disease, is an uncommon inflammatory disorder where one’s immune system fails to fight external threats; rather, it mistakenly attacks the sufferer’s own body. Symptoms include fatigue, numbness, tingling and unprompted pains.
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