Leo’s single-dose autoinjector secures FDA approval for atopic dermatitis
13 Jun 2024
Clinical ResultDrug ApprovalPhase 2Phase 3
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Source: Pharmaceutical Technology
Adbry targets the cytokine IL-13, which drives inflammatory processes of symptoms commonly seen in atopic dermatitis. Credit: Pormezz / Shutterstock.
Leo Pharma has announced that its injection treatment for atopic dermatitis, Adbry (tralokinumab-ldrm), will gain an alternative mode of administration following a US Food and Drug Administration (FDA) approval for its single-dose autoinjector.
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Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes associated with the symptoms of atopic dermatitis. Adbry is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, following a December 2021 approval.
According to GlobalData’s consensus forecasts, Adbry is expected to generate global sales of $1.3bn in 2030. The treatment produced net global sales of $106m in 2023. GlobalData is the parent company of Pharmaceutical Technology.
As per the 13 June press announcement, the treatment will now be available for adult patients as a 300 mg/2 mL single dose autoinjector treatment as another option to the existing 150 mg/1 mL pre-filled injectable, which will continue to be available in the US. Leo Pharma is taking steps to make the newly approved device available to US patients in the coming months, EVP and President, Region North America at Leo Pharma, Brian Hilberdink said in the press release.
“We understand that no patient is the same, and through this extended approval we have taken a positive step forward to equip those living with atopic dermatitis with more choices,” said Shannon Schneider, Senior Medical Affairs Director at LEO Pharma.
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Ballerup, Denmark-based LEO is not the only pharma making strides in the atopic dermatitis space. As per a GlobalData report, the atopic dermatitis market is predicted to be worth $24.4bn across the 61 geographical markets in 2030, with 71.8% of that coming from the seven major markets of US, France, Germany, Italy, Spain, UK, and Japan.”
Earlier in the week, Denmark-based Union Therapeutics shared positive data from its Phase IIb ADESOS study (NCT05469464) which evaluated orismilast as an oral treatment for moderate- to-severe atopic dermatitis. Union is looking to initiate a Phase III programme and has reached out to the FDA with initial plans.
Also in the picture is Dermavant’s nonsteroidal topical nonsteroidal, VTAMA (tapinarof), which received FDA acceptance for its supplemental New Drug Application (sNDA). According to GlobalData’s analysts, atopic dermatitis presents a mine of opportunities, particularly for drugs that target AhR due to the low rate of adverse effects seen in previous clinical trials.
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