CSL Bering Gets FDA Orphan Designation for Hizentra

By Colin Kellaher

CSL Ltd.'s (CSL.AU) CSL Behring unit Monday said it received orphan-drug exclusivity from the U.S. Food and Drug Administration for Hizentra as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy, or CIDP.

CSL said the decision provides a seven-year period of U.S. marketing exclusivity for Hizentra in the maintenance treatment of CIDP with subcutaneous immunoglobulin.

The FDA in March 2018 approved Hizentra to prevent relapse of neuromuscular disability and impairment in adults with CIDP, a rare autoimmune disorder that affects the peripheral nerves and has the potential to cause significant disability.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 09, 2019 08:57 ET (13:57 GMT)

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