General Information

Tarpeyo (budesonide) delayed release capsules is a corticosteriod.

Tarpeyo is specifically indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, , generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.

Tarpeyo is supplied as capsules for oral administration. The recommended dosage is 16 mg administered orally once daily, in the morning at least 1 hour before a meal. Swallow whole. Do not open, crush or chew. When discontinuing, reduce dosage to 8 mg once daily for the last two weeks.

Mechanism of Action

Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. Mucosal B-cells present in the ileum, including the Peyer’s patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. Through their anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, corticosteroids can modulate B-cell numbers and activity. It has not been established to what extent TARPEYO’s efficacy is mediated via local effects in the ileum vs systemic effects.

Side Effects

Adverse effects associated with the use of Tarpeyo may include, but are not limited to, the following:

• hypertension
• peripheral edema
• muscle spasms
• acne
• dermatitis
• weight increase
• dyspnea
• face edema
• dyspepsia
• fatigue
• hirsutism

Clinical Trial Results

Tarpeyo was  approved under accelerated approval.

The FDA accelerated approval was based on achieving the primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study, an ongoing, randomized, double-blind, placebo-controlled, multicenter study conducted to evaluate the efficacy and safety of Tarpeyo 16 mg once daily vs placebo in adult patients with primary IgAN. The effect of Tarpeyo was assessed in patients with biopsy-proven IgAN, eGFR ≥35 mL/min/1.73 m2, and proteinuria (defined as either ≥1 g/day or UPCR ≥0.8 g/g) who were on a stable dose of maximally-tolerated RAS inhibitor therapy. Patients taking Tarpeyo (n=97) showed a statistically significant 34% reduction in proteinuria from baseline vs 5% with RASi alone (n=102) at 9 months. The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key demographic and baseline disease characteristics.