FDA grants 7-year orphan drug exclusivity period for Tarpeyo
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Key takeaways:
- The FDA approved Tarpeyo in December 2023 after the 2-year, phase 3 NefIgArd clinical trial.
- It is made to reduce kidney function loss in adults with primary immunoglobulin A nephropathy.
The FDA has granted a 7-year orphan drug exclusivity period for Tarpeyo, a medication for the treatment of primary immunoglobulin A nephropathy, according to a press release.
Tarpeyo (budesonide, Calliditas Therapeutics) is intended to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
“We are delighted to have [7] years of market exclusivity expiring in December 2030 for Tarpeyo in the [United States], reflecting the new indication based on the long-term data generated,” Renée Aguiar-Lucander, Calliditas CEO, said in the release.
The FDA approved Tarpeyo in December 2023, based on data from the 2-year multicenter, double-blind phase 3 NefIgArd clinical trial of 364 patients. Researchers found the drug had statistically significant advantage over placebo in eGFR. The 2018 to 2021 study, including 9 months of active treatment and a 15-month post-treatment period, showed a consistent outcome across patients regardless of baseline urine protein-to-creatinine ratio and a disparity of 3 mL/min per year in the 2-year eGFR total slope between Tarpeyo and placebo.
Reference:
Lafayette R, et al. Lancet. 2023;doi.org/10.1016/S0140-6736(23)01554-4.
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