China grants first approval for IgA nephropathy drug

2023-11-24

临床3期临床结果上市批准

Calliditas Therapeutics' partner Everest Medicines announced that Chinese regulators have approved Nefecon, a targeted-release formulation of oral budesonide, for adults with primary IgA nephropathy (IgAN) at risk of disease progression, making it the first drug with an IgAN indication cleared in the country. The treatment was previously okayed by regulators in the US in 2021 under the name Tarpeyo and in the EU last year as Kinpeygo.

As with the earlier regulatory decisions, the latest approval was backed by results from the Phase III NefIgArd trial, which evaluated a once-daily dose of the drug in adult patients with primary IgAN on optimised RAS inhibitor therapy. Nefecon demonstrated a significant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over a two-year period consisting of 9-months of treatment and 15-months of follow-up off drug. Further, the reduction in urine protein creatinine ratio seen with Nefecon was also "durable," while the proportion of patients with microhaematuria in the Nefecon group declined, the company said.

Benefits in Chinese subgroup data

Meanwhile, Everest noted that a Chinese subpopulation analysis, presented at the recent American Society of Nephrology (ASN) conference, found "numerically greater magnitude" of Nefecon treatment effect compared with placebo in kidney function, proteinuria and microhaematuria. Specifically, Nefecon was associated with 66% less eGFR deterioration at 24 months versus global data showing 50% less function loss without the drug. Patients in China also achieved greater reductions of 43% in proteinuria at 24 months and 31% at 9 months with Nefecon versus placebo, compared to approximately 30% global reductions at both timepoints.

"Compared with European and American populations, Chinese IgAN patients have faster disease progression and worse prognoses," noted Zhang Hong, a member of the global steering committee for the NefIgArd study, adding that the new approval "helps fill the gap in targeted treatment of IgAN and allows this first-in-disease therapy to benefit more Chinese patients."

Everest CEO Rogers Yongqing Luo said the company is preparing for the commercial launch of Nefecon. The drug was made available through an early-access programme at the Hainan subsidiary of Ruijin Hospital in April. Everest also anticipates approvals for Nefecon Nefecon in Singapore and Hong Kong "in the near term."

In the US, Calliditas is awaiting an FDA decision on whether to convert the accelerated approval for Tarpeyo there into a full approval. An action date has been set for December 20. For additional analysis, see KOL Views Q&A: Leading nephrologist envisages how Novartis, Travere readouts will impact IgAN algorithm.

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