LEO Pharma’ Adtralza (tralokinumab) Receives EC’s Approval for Moderate-To-Severe Atopic Dermatitis

Shots:

• The approval is based on efficacy & safety results from the P-III ECZTRA 1, 2 & 3 trials which evaluates Adtralza (300mg, SC) as monthx vs PBO in 1900+ adult patients with a mod. to sev. AD who are candidates for systemic therapy
• Results: improvement in signs & symptoms with treatment response rates gradually improved & maintained over time, was generally well tolerated with an overall frequency & severity of AEs & reduce itch, improve QoL
• The EC decision is valid in all EU member states, Iceland, Norway & Liechtenstein while regulatory filings are ongoing with MHRA in the UK & other health authorities globally. The approval marks the 1st high-affinity mAb approved therapy to inhibit IL-13 cytokine

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