Spevigo FDA Approval History
Last updated by Judith Stewart, BPharm on March 20, 2024.
FDA Approved: Yes (First approved September 1, 2022)
Brand name: Spevigo
Generic name: spesolimab-sbzo
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Generalized Pustular Psoriasis
Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis.
- Spevigo is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
- Generalized pustular psoriasis (GPP) is a rare and extreme form of psoriasis characterized by repeated episodes in which large areas of skin become red and inflamed and develop small pustules. It is caused by changes in the IL36RN gene which provides instructions for making a protein called interleukin 36 receptor antagonist (IL-36Ra).
- Spevigo works by blocking the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.
- Spevigo is administered as a single dose by intravenous infusion over 90 minutes for the treatment of GPP flares. If flare symptoms persist, an additional dose may be administered one week after the initial dose.
Spevigo is administered by subcutaneous injection every four weeks for the treatment of GPP when not experiencing a flare, and every four weeks starting four weeks after receiving an intravenous infusion for the treatment of a flare. - Warnings and precautions associated with Spevigo include lowered ability to fight infections and hypersensitivity and infusion-related reactions. Live vaccines should not be administered concurrently.
- Common adverse reactions of the intravenous injection formulation used to treat GPP flares include asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
Common adverse reactions of the subcutaneous injection formulation used to treat GPP without a flare include urinary tract infection, arthralgia, and pruritus.
Development timeline for Spevigo
Further information
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