Everest receives Singapore HSA approval for NEFEGAN to treat IgAN
20 Mar 2024
Clinical ResultPhase 3Drug ApprovalNDA
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Source: Pharmaceutical Technology
NEFEGAN demonstrated clinically meaningful results over placebo. Credit: Peakstock via Shutterstock.
Everest Medicines has received approval from the Singapore Health Sciences Authority (HSA) for NEFEGAN to treat primary immunoglobulin A nephropathy (IgAN) in adults at disease progression risk.
An oral, delayed-release budesonide formulation, NEFEGAN is also known as Nefecon in other regions and is the first medication for IgAN, having received the first full approval from the US Food and Drug Administration.
Singapore is the third region within Everest’s territories to approve the new drug application (NDA), following mainland China and Macao.
The efficacy and safety of Nefecon were evaluated in the Phase III NefIgArd clinical trial.
This randomised, double-blind, multicentre study tested a once-a-day dose of 16mg Nefecon against a placebo in adults with primary IgAN who were also receiving optimised angiotensin system inhibitors therapy.
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Spanning over two years, the NefIgArd trial included nine months of treatment with either Nefecon or a placebo, succeeded by a follow-up period of 15 months without the study drug.
The time-weighted average of the estimated glomerular filtration rate (eGFR) over two years was the trial’s primary endpoint.
The findings showed that Nefecon offered a statistically significant and clinically meaningful benefit over a placebo.
Additionally, the trial demonstrated a favourable two-year total eGFR slope difference of 2.95ml per minute and 1.73m² per year with Nefecon treatment.
These benefits were consistent across the entire study population, irrespective of the baseline level of urine protein-creatinine ratio.
An in-depth analysis of the full two-year results from the NefIgArd trial, which involved 364 patients, was conducted to examine the response to Nefecon treatment based on self-reported ancestry.
Among the participants, 83 identified as Asian and 275 as White. In both subgroups, Nefecon’s 16mg a day dosage over nine months led to a clinically meaningful preservation of kidney function, with a reduction in proteinuria and stabilisation of eGFR compared to placebo.
Everest CEO Rogers Yongqing Luo said: “The NDA approval in Singapore marks an important event for IgAN patients in the region as we continue to expand patient access to Nefecon throughout Asia, an area of high IgAN disease prevalence.
“Following approval of Nefecon in mainland China and commercial launch in Macao, we are working to rapidly expand availability of this first-in-disease therapy which targets the origin of the disease and can slow disease progression to more underserved patients in 2024, including Hong Kong, Taiwan and South Korea.”
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