Ligelizumab

Published

dm+d

Unassigned

New Medicines

Prevention of food allergic reactions

Information

New molecular entity
Novartis
Novartis

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

A humanised anti-IgE monoclonal antibody, that belongs to the IgG1/κ isotype subclass.
Levels of food allergy seem to be rising. Reasons for this are unclear but it may be connected with the processed nature of the western diet and its effects on the gut microbiome. It is difficult to find accurate numbers for prevalence of food intolerance or allergy. Some studies have shown that self-reporting of food-related symptoms may not be confirmed in food challenge studies [1].
Prevention of food allergic reactions
Subcutaneous injection

Chronic spontaneous or idiopathic urticaria

Information

New molecular entity
Novartis
Novartis

Development and Regulatory status

Discontinued
Discontinued
Discontinued
May 22Development discontinued. Following extensive evaluation of PEARL data, Novartis decides not to proceed with submitting and launching ligelizumab in CSU at this time. Currently, the PIII PEARL studies remain ongoing [14].

Category

A humanised anti-IgE monoclonal antibody, that belongs to the IgG1/κ isotype subclass.
Prevalence rate for chronic urticaria has been estimated as 1-5 per 1,000 [3].
Chronic spontaneous or idiopathic urticaria
Subcutaneous injection

Further information

Yes

Trial or other data

Dec 21Novartis announces PEARL 1 and PEARL 2 (NCT03580369 and NCT03580356) met the primary endpoint of superiority against placebo at 12 weeks. However, ligelizumab failed to show superiority vs omalizumab. [12]

Evidence based evaluations