LEO Pharma’s Adtralza (tralokinumab) Receives the Health Canada’s Approval for the Treatment of Atopic Dermatitis
Shots:
- Health Canada has approved Adtralza for adolescents aged 12-17yrs. with sev. AD whose disease is not adequately controlled with topical prescription therapies or those therapies are not advisable
- The approval was based on the P-III trial (ECZTRA 6) results evaluating Adtralza (150/300mg) monotx. with/out topical corticosteroids vs PBO in 289 adolescents. The recommended dosage is 600mg loading dose, followed by 300mg, EOW
- The trial met its 1EPs @16wk. as measured by an IGA score of clear or almost clear skin (IGA 0/1), 75% improvement in EASI score (EASI-75) & the trial also met its 2EPs i.e., reduction in itch with ≥4-point improvement in adolescent WP-NRS from baseline. Adtralza is a human mAb that binds to & inhibits IL-13 cytokine
Ref: Newswire | Image: Leo Pharma
Related News:- LEO’s Adtralza Receives EC's Approval for the Treatment of Moderate to Severe Atopic Dermatitis
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