-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
AstraZeneca announced Wednesday that the European Commission has approved Saphnelo (anifrolumab) as an add-on therapy for the treatment of adults with moderately to severely active autoantibody-positive systemic lupus erythematosus (SLE)
.
"Saphnelo is the first new SLE medicine to be approved in Europe in over a decade," said Mene Pangalos, executive vice president of Biopharmaceuticals R&D at AstraZeneca
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by multiple systemic and multiple organ involvement, repeated relapse and remission, and the presence of a large number of autoantibodies in the body.
It can cause irreversible damage to the involved organs and eventually lead to the death of the patient
.
The etiology of SLE is complex and is related to various factors such as genetics, sex hormones, and the environment (such as viral and bacterial infections
immune infection
Saphnelo (anifrolumab) is a type I interferon receptor antibody that was recently approved for the treatment of SLE in the United States, Japan and Canada
.
The European approval was supported by the Phase III TULIP-1 and -2 studies and the interim MUSE trial investigating the efficacy and safety of intravenous Saphnelo (anifrolumab) in patients with moderate to severe SLE
In the TULIP-2 study, a total of 362 patients received the randomized intervention: 180 received anifrolumab and 182 received placebo
.
The percentage of patients achieving remission was 47.
The percentage of patients achieving remission was 47.
AstraZeneca is currently conducting a Phase III trial to study the efficacy and safety of subcutaneous administration of Saphnelo in SLE, with additional late-stage trials planned for lupus nephritis, cutaneous lupus erythematosus and myositis
Original source:
Original source:https://firstwordpharma.
https://firstwordpharma.
com/story/5500243 https://firstwordpharma.
com/story/5500243 Leave a comment here
