Tarpeyo FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 2, 2024.
FDA Approved: Yes (First approved December 15, 2021)
Brand name: Tarpeyo
Generic name: budesonide
Dosage form: Delayed Release Capsules
Previous Name: Nefecon
Company: Calliditas Therapeutics AB
Treatment for: Immunoglobulin A Nephropathy
Tarpeyo (budesonide) is a targeted release formulation of the approved corticosteroid budesonide indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
- Tarpeyo was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Tarpeyo is now a fully FDA-approved treatment for IgAN based on a measure of kidney function.
- IgA nephropathy is a rare kidney disease that occurs when IgA deposits build up in the kidneys. Tarpeyo works by targeting mucosal B-cells which are responsible for the production of galactose-deficient IgA1 antibodies that cause IgA nephropathy.
- Tarpeyo delayed release capsules are administered orally once daily, in the morning at least 1 hour before a meal.
- Common adverse reactions include peripheral edema, hypertension, muscle spasms, acne, headache, upper respiratory tract infection, face edema, increased weight, dyspepsia, dermatitis, arthralgia, and increased white blood cell count.
Development timeline for Tarpeyo
Further information
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