Pharma Focus Asia

Everest Medicines Receives Approval from Singapore Health Sciences Authority for NEFEGAN® in Treating Primary IgA Nephropathy Among Adult Patients

Wednesday, March 20, 2024

Everest Medicines (HKEX 1952.HK, "Everest"), a biopharmaceutical company focused on developing innovative medicines and vaccines, has announced that the Singapore Health Sciences Authority (HSA) has approved NEFEGAN® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. NEFEGAN®, also known as Nefecon® in other Everest territories, was the first IgAN treatment to gain full approval from the U.S. Food and Drug Administration. This marks the third region within Everest's territories, after Macao and mainland China, to receive New Drug Application (NDA) approval.

Rogers Yongqing Luo, CEO of Everest Medicines, stated, "This NDA approval in Singapore is a significant milestone for IgAN patients in the region as we continue our mission to broaden access to Nefecon® across Asia, where there is a high prevalence of IgAN." Luo added, "Following the approval of Nefecon® in mainland China and its commercial launch in Macao, our focus now is on swiftly expanding availability of this pioneering therapy to more underserved patients in 2024, including those in Hong Kong, Taiwan, and South Korea."

The Phase 3 NefIgArd clinical trial evaluated Nefecon® at a once-daily dose of 16 mg compared to placebo in adult patients with primary IgAN receiving optimized RASi therapy. This two-year trial included nine months of treatment with Nefecon® or placebo followed by a 15-month follow-up period off the study drug. The primary endpoint, time-weighted average of eGFR over two years, demonstrated a statistically significant and clinically meaningful benefit of Nefecon® over placebo. Additionally, there was a difference in the 2-year total eGFR slope of 2.95 mL/min per 1.73 m2 per year in favor of Nefecon®.

The comprehensive two-year results of the NefIgArd trial (n=364 patients) were further analyzed to explore potential differences in response to Nefecon® treatment based on self-reported Asian (n=83) or White (n=275) ancestry in patients with IgAN. Treatment with Nefecon® 16 mg/day over a 9-month period led to clinically meaningful preservation of kidney function in both subgroups, as evidenced by reductions in proteinuria and stabilization of eGFR compared to placebo.

Nefecon® is a patented oral, delayed-release formulation of budesonide, a corticosteroid designed to target mucosal B-cells present in the ileum, where the disease originates according to predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive license agreement with Calliditas, granting Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was expanded in March 2022 to include South Korea in Everest Medicine's territories. NEFEGAN® is the brand name in Singapore.



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