In the final hours of 2021, the FDA approved a number of new drugs. One of these therapies is Adbry (tralokinumab-ldrm) from Leo Pharma. Adbry, an interleukin-13 antagonist, is indicated for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Tralokinumab is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.
There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease
Leo Pharma did not announce pricing at this time.
ICER published the following price references (including their estimate for Adbry):
Tralokinumab (Adbry) — $25,700-$35,000 per year (estimate)
Abrocitinib — $30,600-$41,800 per year.
Olumiant — $24,400-$33,300 per year (US list price: $29,000)
Rinvoq — $30,400-$41,500 per year (US list price: $64,300)
Dupixent — $29,000-$39,500 per year (US list price: $41,800)
Adbry is supplied in 150 mg pre-filled syringes for Sub-Q administration. The initial dose of 600 mg (four 150 mg injections) is followed by 300 mg (two 150 mg injections) administered every other week.
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022. Given the size of the size of the potential patient population and that the other therapies in this segment are not in limited distribution, it is likely Adbry will not be launched through LD.
LEO Pharma announces FDA approval of Adbry (tralokinumab-ldrm)
The first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
MADISON, N.J. — December 28, 2021 (BUSINESS WIRE)–LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4
“Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”
“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”
The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1
In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1
In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1
“Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control, but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. “Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”