|Trade names||Adtralza, Adbry|
|Other names||CAT-354, tralokinumab-ldrm|
|Main uses||Atopic dermatitis|
|Side effects||Upper respiratory tract infections, reactions at the injection site, eye pain and redness|
|Typical dose||300 mg q 2 wks|
|Chemical and physical data|
|Molar mass||143875.20 g·mol−1|
Tralokinumab, sold under the brand names Adtralza and Adbry, is a medication used to treat atopic dermatitis. Specifically it is used for moderate to severe disease which is not controlled by medication applied to the skin. It is given by injection under the skin.
Common side effects include upper respiratory tract infections such as the common cold, reactions at the injection site, and eye pain and redness. Other side effects may include anaphylaxis and angioedema. While there is no evidence of harm in pregnancy, such use has not been well studied. It is a monoclonal antibody which blacks the activity of cytokine interleukin 13.
Tralokinumab was approved for medical use in Europe, the United States, and the United Kingdom in 2021. In the United Kingdom it costs the NHS about £1070 for 600 mg as of 2022. This amount in the United States costs about 3,300 USD.
Tralokinumab is used for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. This includes moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
About 10% more people have clear or almost clear skin with its use.
Tralokinumab was discovered by Cambridge Antibody Technology scientists using protein optimization based on Ribosome Display. They used the extensive data sets from ribosome display to patent protect CAT-354 in a world-first of sequence-activity-relationship claims. In 2004, clinical development of CAT-354 was initiated with this first study completing in 2005. On 21 July 2011, MedImmune LLC initiated a Phase IIb, randomized, double-blind study to evaluate the efficacy of tralokinumab in adults with asthma.
In 2016, MedImmune and AstraZeneca started developing tralokinumab for asthma (Phase III) and atopic dermatitis (Phase IIb) while clinical development for moderate-to-severe ulcerative colitis and idiopathic pulmonary fibrosis (IPF) have been discontinued. In July of that year AstraZeneca licensed tralokinumab to Leo Pharma for skin diseases.
A phase IIb study of tralokinumab found that treatment was associated with early and sustained improvements in atopic dermatitis symptoms and tralokinumab had an acceptable safety and tolerability profile, thereby providing evidence for targeting IL-13 in patients with atopic dermatitis.
Society and culture
On 22 April 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Adtralza, intended for the treatment of moderate‑to‑severe atopic dermatitis. The applicant for this medicinal product is LEO Pharma A/S. Tralokinumab was approved for medical use in the European Union in June 2021.
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