FDA grants full approval of Tarpeyo for IgA nephropathy
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Key takeaways:
- Tarpeyo is the first fully FDA-approved drug for IgA nephropathy based on a measure of kidney function.
- The drug is available through Calliditas Therapeutics’ specialty pharmacy.
The FDA has granted full approval for Tarpeyo delayed-release capsules to reduce the loss of kidney function in adults with IgA nephropathy who are at risk for disease progression, according to a press release.
Tarpeyo (budesonide, Calliditas Therapeutics) is an oral 4 mg B-cell immunomodulator designed to target pathogenic galactose-deficient IgA1 antibodies, which may cause IgA nephropathy (IgAN). The drug is intended to treat proteinuria in adults with primary IgAN at risk for rapid disease progression, regardless of proteinuria levels, according to the release. It is the first fully FDA-approved treatment for IgAN based on a measure of kidney function, and the only FDA-greenlit therapy for primary IgAN that may reduce the loss of kidney function, according to the release.
“We are thrilled that adult IgAN patients at risk for progression in the United States can now have access to this pioneering treatment option that could help preserve their kidney function and, hence, impact the progression of their disease,” Renee Aguiar-Lucander, CEO of Calliditas, said in the release. “This medicine was specifically developed to target an underlying cause of IgAN.”
Tarpeyo was initially authorized in 2021 under accelerated FDA approval. The full approval is based on multicenter, double-blind phase 3 NefIgArd clinical trial data, according to the release. During a 2-year study period of 364 patients from 2018 to 2021, which ran for 9 months of active treatment followed by a 15-month post-treatment period, researchers found the drug had a statistically significant advantage over placebo in eGFR. The outcome was consistent across all patients, regardless of baseline urine protein-to-creatinine ratio, and showed a disparity of 3 mL/min per year in the 2-year eGFR total slope between Tarpeyo and placebo.
The drug is available through the company’s specialty pharmacy, Biologics by McKesson.
References:
Calliditas Therapeutics announces full results from the NefIgArd phase 3 trial published in The Lancet. https://www.calliditas.se/en/calliditas-therapeutics-announces-full-results-from-the-nefigard-phase-3-trial-published-in-the-lancet/. Published Aug. 15, 2023. Accessed Dec. 20, 2023.
Lafayette R, et al. Lancet. 2023;doi.org/10.1016/S0140-6736(23)01554-4
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