Everest receives Singapore HSA approval for NEFEGAN to treat IgAN

20 Mar 2024
www.pharmaceutical-technology.com
Clinical ResultPhase 3Drug ApprovalNDA
NEFEGAN demonstrated clinically meaningful results over placebo. Credit: Peakstock via Shutterstock.
NEFEGAN 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.
Everest Medicinesrelease budesonide formulation, NEFEGAN is also known as Nefecon in other regiNEFEGAN is the fiprimary immunoglobulin A nephropathy (IgAN)e first full approval from the US Food and Drug Administration.
Singapore is the third rebudesoniden Everest’s teNEFEGANes to approve the Nefecong application (NDA), following mainland China and IgANo.Food and Drug Administration
The efficacy and safety of Nefecon were evaluated in the Phase III NefIgArd clinical trial.
This randomised, double-bliNefeconticentre 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.
FDA time-weigBoehringerge SPEVIGOestimpsoriasiserular 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 Nefeconper 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 tNefecon 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 Nefeconinically 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-dNefecontherapy 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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