Novartis Gets FDA Breakthrough-Therapy Designation for Ligelizumab
January 14 2021 - 7:07AM
Dow Jones News
By Colin Kellaher
Novartis AG on Thursday said the U.S. Food and Drug
Administration granted breakthrough-therapy designation to
ligelizumab for the treatment of the skin disease chronic
spontaneous urticaria in patients who have an inadequate response
to H1-antihistamine treatment.
The Swiss drug maker said there are currently limited approved
therapies for patients with chronic spontaneous urticaria, also
known as chronic idiopathic urticaria, an unpredictable and severe
skin disease that affects 0.5% to 1% of the global population at
any time.
The FDA's breakthrough-therapy designation aims to expedite the
development and review of a drug for serious conditions when
preliminary clinical evidence shows the drug may show substantial
improvement over available therapies.
Novartis said it expects to file for U.S. approval of
ligelizumab in chronic spontaneous urticaria in 2022.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 14, 2021 06:52 ET (11:52 GMT)
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