Spesolimab

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. See Also: Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval FDA approves Boehringer’s SPEVIGO for psoriasis treatment 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.”

The product is suitable for patients 12 years and above weighing a minimum of 40kg. Credit: Melnikov Dmitriy via Shutterstock. The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim’s SPEVIGO injection to treat generalised pustular psoriasis (GPP). The treatment is indicated for use in adult and paediatric patients 12 years and above with a minimum weight of 40kg. This development follows a similar approval by the Chinese National Medical Products Administration for reducing GGP occurrence in patients of the same age group. A humanised selective IgG1 antibody, SPEVIGO attaches to the interleukin-36 receptor, which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. The FDA’s decision was largely based on the positive outcomes of the EFFISAYIL 2 clinical trial. See Also: Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval Everest receives Singapore HSA approval for NEFEGAN to treat IgAN The 48-week study, involving 123 patients, demonstrated that SPEVIGO significantly reduced GPP flare risk by 84% versus placebo. Remarkably, after week four, no flares were observed in the high-dose SPEVIGO group. However, the trial also reported an increased incidence of certain adverse events associated with SPEVIGO treatment. These included reaction at the injection site, urinary tract infection, arthralgia, and pruritus, occurring at a rate of at least nine cases per 100 patient-years compared to the placebo arm. Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “SPEVIGO’s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment. “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode. Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.” This month, Boehringer signed a global collaboration and exclusive option-to-license agreement with Sosei Heptares for the development of a new class of therapies for all schizophrenia symptoms. Under the deal, the companies will develop and market a portfolio comprising G protein-coupled receptor 52 agonists from Sosei Heptares to treat positive, negative, and cognitive symptoms linked to schizophrenia.