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CSL secures regulatory approval in Japan for 2 autoimmune disorder drugs

CSL Ltd. said Japan's Ministry of Health, Labour and Welfare approved two autoimmune disorder medicines, Hizentra and Privigen, for treating a rare autoimmune disorder.

Australia-based CSL's Hizentra and Privigen are now approved in Japan for treating chronic inflammatory demyelinating polyneuropathy, a disorder that targets the peripheral nerves and may cause permanent nerve damage.

Hizentra and Privigen are both immunoglobulins, a protein developed by plasma cells to neutralize bacteria and viruses. Hizentra is administered under the skin, while Privigen is injected into the veins.

According to a March 26 press release, the approval of Hizentra is based on results from a late-stage study, called Polyneuropathy and Treatment with Hizentra, or PATH, while Privigen's approval was supported by the results of both the PATH study and a phase 3 trial, called Privigen Impact on Mobility and Autonomy study, or PRIMA.

Patients' response to Privigen, measured by the ability to walk and perform tasks, was 73% and 61% in the PATH and PRIMA studies, respectively.

The U.S. Food and Drug Administration has approved Privigen and Hizentra to treat patients with chronic inflammatory demyelinating polyneuropathy.