FDA Approves Tralokinumab-ldrm Autoinjector for Adults With Atopic Dermatitis

The FDA has approved a new tralokinumab-ldrm (Adbry; LEO Pharma) 300 mg single-dose autoinjector for adult patients with moderate-to-severe atopic dermatitis. Tralokinumab-ldrm is currently indicated for moderate-to-severe atopic dermatitis in patients aged 12 years and older.¹

According to a news release, the autoinjector will provide another option for adults in addition to the prefilled syringe that is currently available. Prior to the autoinjector, tralokinumab-ldrm was only available in a 1 mL prefilled syringe. The new 2 mL autoinjector offers patients another, more convenient option with half the number of required injections compared with the 1 mL prefilled syringe.¹

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“We are constantly looking for new ways to advance the standard of care and improve the patient experience for our treatment options,” said Brian Hilberdink, executive vice president and president, Region North America, for LEO Pharma, in a news release. “Through this latest approval, a new mode of administration has been made available to provide a more convenient option to support self-administration.”¹

Tralokinumab-ldrm is a high-affinity fully human monoclonal antibody. It is designed to bind to and inhibit the interleukin-13 cytokine, which is involved in the immune and inflammatory processes underlying the signs and symptoms of atopic dermatitis.¹

The initial FDA approval of tralokinumab-ldrm, in December 2021, was based on evidence from 3 clinical trials of 1934 patients with moderate-to-severe atopic dermatitis that was not adequately controlled by topical medications. Of the 1934 participants, 1130 were male, 1329 were White, and 1835 were younger than 65 years.²

In the ECZTRA 1 and ECZTRA 2 trials, adults with moderate-to-severe atopic dermatitis were randomized 3:1 to subcutaneous tralokinumab-ldrm 300 mg every 2 weeks or placebo. Primary end points were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and 75% or greater improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients who achieved an IGA score of 0 or 1 and/or EASI 75 with tralokinumab-ldrm at week 16 were then re-randomized to tralokinumab-ldrm every 2 weeks or every 4 weeks, or placebo, for 36 weeks.³

According to the findings, more patients who received tralokinumab-ldrm versus placebo achieved an IGA score of 0 or 1, with 15.8% and 7.1%, respectively, in ECZTRA 1, and 22.2% and 10.9%, respectively, in ECZTRA 2. Similar results were seen with EASI 75, with 25% of patients with tralokinumab-ldrm versus 12.7% with placebo in ECZTRA 1, and 33.2% vs 11.4%, respectively, in ECZTRA 2. Researchers also observed early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis, and Patient-Oriented Eczema Measure among patients receiving tralokinumab-ldrm.³

Furthermore, the majority of week 16 tralokinumab-ldrm responders maintained response at week 52 with continued tralokinumab-ldrm treatment without any rescue medications, including topical corticosteroids. Adverse events were reported in 76.4% and 61.5% of patients receiving tralokinumab-ldrm in ECZTRA 1 and ECZTRA 2, respectively, and in 77% and 66% of patients receiving placebo in ECZTRA 1 and ECZTRA 2, respectively.³

The newly-approved autoinjector further enables patients to receive convenient treatment with tralokinumab-ldrm. However, the pre-filled syringe will continue to be available for patients who prefer that option, according to the news release.¹

“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, in the news release. “Alongside the previously approved pre-filled syringe, the autoinjector will give adult patients in the US more options than ever before in how they administer their treatment.”¹

References

1. FDA Approves Adbry (tralokinumab-ldrm) Autoinjector for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis (AD). News release. LEO Pharma. June 13, 2024. Accessed June 13, 2024. https://www.businesswire.com/news/home/20240613529061/en/FDA-Approves-Adbry%C2%AE-tralokinumab-ldrm-Autoinjector-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Atopic-Dermatitis-AD

2. Drug Trials Snapshots: Adbry. FDA. Updated September 19, 2023. Accessed June 13, 2024. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adbry

3. Wollenberg A, Blauvelt A, Guttman-Yassky E, et al. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicenter, placebo-controlled phase III trials (ECZTRA 1 AND ECZTRA 2). Br J Dermatol. 2021;184(3):437-449. doi:10.1111/bjd.19574