Novartis Gets FDA Breakthrough-Therapy Designation for Ligelizumab

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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