Adbry FDA Approval History
Last updated by Judith Stewart, BPharm on June 24, 2024.
FDA Approved: Yes (First approved December 27, 2021)
Brand name: Adbry
Generic name: tralokinumab-ldrm
Dosage form: Injection
Company: LEO Pharma Inc.
Treatment for: Atopic Dermatitis
Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist used for the treatment of moderate-to-severe 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 or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids.
- Adbry is the first FDA approved biologic that specifically binds to and inhibits the interleukin-13 cytokine, a key driver of atopic dermatitis signs and symptoms.
- Adbry is administered via subcutaneous injection every other week. A dosing interval of every four weeks may be considered for adult patients <100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
- Adbry is supplied as a single-dose prefilled syringe (for use in adults and pediatric patients 12 years of age and older) and a single-dose autoinjector (for use in adults only).
- Warnings and precautions associated with Adbry include serious hypersensitivity reactions, conjunctivitis and keratitis, parasitic (helminth) infections, and risk of infection with live vaccines.
- Common adverse reactions include upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.
Development timeline for Adbry
Further information
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