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NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis

The recommendation will give those living with the condition in England and Wales access to a new treatment option

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LEO Pharma has announced that its biologic treatment for moderate-to-severe atopic dermatitis, Adtralza (tralokinumab), has been issued a final appraisal document for recommendation by the National Institute for Health and Care Excellence (NICE).

The recommendation is specifically for adult patients with the condition who are eligible for systemic treatment, only if the disease has not responded to at least one systemic immunosuppressant, or if these are not suitable.

The decision from NICE follows a multiple technology appraisal (MTA) and its recommendation simultaneously approves Adtralza, Rinvoq (upadacitinib) and Cibinqo (abrocitinib) for reimbursement following use in NHS England and Wales, which is based upon both cost-effectiveness and a demonstration of positive patient outcomes.

NICE based its recommendation on results from four randomised, multi-centre phase 3 studies – ECZTRA 1, ECZTRA 2, ECZTRA 3 – which supported the efficacy and safety of Adtralza in patients with moderate-to-severe atopic dermatitis. ECZTRA 7 was conducted as a branch of the study assessing patients with severe disease.

The four studies showed that Adtralza improved signs and symptoms of atopic dermatitis at 16 weeks when compared with placebo, as monotherapy or in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

The treatment is available in a prefilled syringe for use as an injection and can be used with or without topical corticosteroids.

Sarah Kleinpeter, vice president and general manager of UK and Ireland at LEO Pharma, said: “NICE’s decision to recommend tralokinumab is an important step for those living with moderate-to-severe atopic dermatitis. We are delighted that this recommendation will give those living with the condition in England and Wales access to a new treatment option. This approval represents the latest innovation from LEO Pharma as we continue to support people living with skin conditions.”  

In 2021, the European Commission approved Adtralza for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK. In January 2022, the Scottish Medicines Consortium accepted Adtralza for use within NHS Scotland.

Article by
Fleur Jeffries

30th June 2022

From: Research, Regulatory



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