Tarpeyo™ (budesonide) is now available 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) of at least 1.5g/g.
To help patients gain access to treatment, Calliditas Therapeutics has launched a patient support program called Tarpeyo Touchpoints. “Now that our drug is commercially available, we are focused on making sure that patients who may benefit from Tarpeyo can access treatment,” said Andrew Udell, President North America, Calliditas Therapeutics. “To that end, we are proud to offer a robust patient support program that offers services and resources including financial assistance, where appropriate.”
The accelerated approval of Tarpeyo was based on data from a phase 3 study (ClinicalTrials.gov Identifier: NCT03643965), which included 299 adults with biopsy-proven IgAN, estimated glomerular filtration rate (eGFR) of at least 35mL/min/1.73m2, and proteinuria (defined as either 1g/day or greater, or UPCR 0.8g/g or greater) who were on a stable dose of maximally-tolerated renin-angiotensin system (RAS) inhibitor therapy. Patients were randomly assigned 1:1 to receive Tarpeyo 16mg once daily or placebo for 9 months, followed by a 2-week taper of Tarpeyo 8mg once daily or placebo.
Results showed that treatment with Tarpeyo was associated with a 34% reduction in UPCR at 9 months compared with a 5% reduction for placebo (treatment difference, 31%; 95% CI, 16-42; P =.0001). The most common adverse reactions reported with Tarpeyo were hypertension, peripheral edema, muscle spasms, acne, dermatitis, increased weight, dyspnea, face edema, dyspepsia, fatigue, and hirsutism.
Tarpeyo is available as a 4mg delayed-release capsule in a 120-count bottle. The delayed release capsules should be swallowed whole in the morning, at least 1 hour before a meal. The consumption of grapefruit juice should be avoided for the duration of Tarpeyo therapy as it can increase the systemic exposure of budesonide.
It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval for the proteinuria indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
- Calliditas Therapeutics announces commercial availability and initial sales of Tarpeyo™. News release. Calliditas Therapeutics AB. Accessed January 28, 2022. https://www.prnewswire.com/news-releases/calliditas-therapeutics-announces-commercial-availability-and-initial-sales-of-tarpeyo-301470452.html.
- Tarpeyo. Package insert. Calliditas Therapeutics; 2021. Accessed January 28, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215935s000lbl.pdf.