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Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing
Cosentyx demonstrated superior improvements of skin symptoms compared to placebo
1
The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials and is consistent with the established adult psoriasis indication
1
Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with onset most common during adolescence
Novartis Pharma AG: Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
Cosentyx demonstrated superior improvements of skin symptoms compared to placebo
1
The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials and is consistent with the established adult psoriasis indication
1
Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with onset most common during adolescence
2,3
Basel, June 1, 2021 - Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx
US breakthrough designation for ligelizumab in chronic spontaneous urticaria
15th January 2021
The US Food and Drug Administration (FDA) has granted Novartis’ ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria (CSU) who have an inadequate response to H1-antihistamine treatment.
Ligelizumab – also known as QGE031 – is a monoclonal anti-immunoglobulin E (IgE) antibody that is though to work by blocking the IgE/FcεRI pathway which is lays a key role in the inflammatory process in CSU.
CSU, which affects 0.5-1% of the global population, is characterised by the development of hive, swelling (angiodema), or both – lasting for at least six weeks and occurring with no known cause.