CSL Bering Gets FDA Orphan Designation for Hizentra
09 Dicembre 2019 - 3:12PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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