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Adbry FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 30, 2021.

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 adult patients 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 patients <100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
  • Adbry may cause serious hypersensitivity reactions. Common adverse reactions include upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.

Development timeline for Adbry

Dec 28, 2021Approval FDA Approves Adbry (tralokinumab-ldrm) for Adults with Moderate-to-Severe Atopic Dermatitis
Jul  9, 2020LEO Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of Biologics License Application (BLA) for Tralokinumab for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis
Jun 12, 2020Tralokinumab Achieves Primary and Secondary Endpoints in Three Pivotal Phase 3 Trials in Adult Patients with Moderate-to-Severe Atopic Dermatitis

Further information

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