Semaglutide(Hainan Zhonghe)

GLASGOW, Scotland, June 4, 2026 /PRNewswire/ -- New findings from the landmark FLOW trial, presented at the 63rd ERA Congress, show that once-weekly semaglutide significantly improved health-related quality of life in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD), equivalent to around eight additional days in full health per year. The trial previously demonstrated that semaglutide reduced the risk of major kidney disease events by 24% and all-cause mortality by 20% compared with placebo over a median treatment duration of 3.4 years. This new analysis provides complementary patient-centred evidence, showing that the benefits of semaglutide may extend beyond traditional clinical outcomes to how patients feel and function in everyday life. For people living with both T2D and CKD, symptoms, treatment burden and reduced physical functioning can substantially affect day-to-day well-being, making quality of life an increasingly important treatment goal. Among 3,533 randomised participants in the FLOW trial, 1,767 received semaglutide and 1,766 received placebo. Health-related quality of life was assessed using the EQ-5D-5L questionnaire, a patient-reported measure of health status and well-being covering mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and overall health perception. After two years of treatment, health utility scores – which range from 0 (death) to 1 (perfect health) – remained stable in the semaglutide group but declined in those receiving placebo. The estimated treatment difference of +0.021 (p=0.0001) corresponded to approximately eight additional days per year spent in full health. Self-rated general health scores also improved with semaglutide but worsened with placebo, with a significant treatment difference of +2.15 (p<0.0001), again becoming worse over time with placebo while stable on semaglutide. Four of the five areas assessed by the questionnaire (mobility, self-care, usual activities, and pain/discomfort) improved significantly with semaglutide compared with placebo. No significant difference was observed in anxiety/depression. Benefits were broadly consistent across patient subgroups. "We were surprised by the extent of the quality-of-life benefits seen with semaglutide, because they were not only clinically meaningful but consistently experienced across multiple aspects of daily life, including physical functioning and overall well-being," said Professor Johannes Mann, study lead author. "We were uncertain about quality-of-life outcomes because gastrointestinal side effects are common with GLP-1 receptor agonists," Prof. Mann furthered. "Our findings confirm that the benefits of semaglutide in chronic kidney disease extend beyond traditional clinical endpoints to subjective outcomes that matter directly to patients." 21% more press release views with Request a Demo

J&J details mid-stage lupus data for FcRn blockerFlush with GLP-1 cash, Lilly casts wider net for dealsFDA begins process of qualifying AI-based liver injury risk modelFDA backs use of existing science to advance gene therapiesWeight-loss drugs linked to fewer knee replacementsJ&J details mid-stage lupus data for FcRn blockerAfter top-lining results in January, Johnson & Johnson unveiled detailed data from the Phase IIb JASMINE study of its FcRn blocker Imaavy (nipocalimab) in adults with moderate-to-severe systemic lupus erythematosus (SLE). The mAb is already approved for generalised myasthenia gravis.Results — to be presented at the European Alliance of Associations for Rheumatology (EULAR) congress — showed that Imaavy met the primary endpoint, with significantly more patients achieving an SLE Responder Index 4 (SRI-4) response at week 24 versus placebo (53.5% vs 46.7%), translating to an odds ratio of 1.6. The response rates were sustained through week 52 (53.6% vs 39.7%), thus meeting a key secondary goal. Notably, in a pre-defined autoantibody-positive population, SRI-4 response rates were markedly higher with Imaavy over placebo (58.2% vs 36.1%). Additionally, more patients in the Imaavy arm achieved Lupus Low Disease Activity State (LLDAS) — a key exploratory endpoint — than placebo recipients (37.5% vs 20.5%). See – KOL Views Q&A: Rheumatologist weighs in on emerging lupus therapies and the need for more comprehensive endpoints.Meanwhile, a late-stage SLE trial of Imaavy, dubbed GARDENIA, is ongoing, while the FcRn blocker is also being evaluated in other autoimmune conditions, including Sjögren's disease. -Pavan KamatFlush with GLP-1 cash, Lilly casts wider net for dealsEli Lilly's acquisition and partnership blitz shows little sign of slowing, with its corporate business development head Jacob Van Naarden suggesting at the American Society of Clinical Oncology (ASCO) meeting that more transactions could push the drugmaker beyond its traditional strongholds.The comments came the same day Lilly announced a partnership worth up to $1.9 billion with Ascidian Therapeutics to develop RNA-editing medicines for kidney diseases. According to CNBC, Lilly has spent more on eight deals announced in the first half of 2026 — committing over $10 billion upfront and up to $25 billion in total — than it did on roughly 40 during all of last year, when it spent about $4 billion."[Our] financial strength right now, driven mostly by the weight loss business, is so strong," Van Naarden said. "We have this…generational opportunity to redeploy that capital in all of our disease areas to not only fuel growth…in the decades to come, but to help a lot more patients with all different kinds of diseases, and so we're executing against that strategy."Some of the deals announced this year fall under Lilly's current specialties of oncology, neuroscience, cardiometabolic health and immunology, though others, like its recent buyouts of three vaccine companies, will take it into new areas (see – Spotlight On: Lilly dives deeper into prevention — five key takeaways). When asked if there was anything off the table, Van Naarden said, "No, not really."-Anna BratulicFDA begins process of qualifying AI-based liver injury risk modelThe FDA said Thursday it has accepted a letter of intent (LOI) for the first in silico drug development tool into its Innovative Science and Technology Approaches for New Drugs (ISTAND) qualification programme. The tool is a digital liver model that predicts the drug-induced liver injury risk of small molecule drug candidates. Developed by Absentia Labs, the model uses AI to compare the chemical structures of new drug candidates against historical reference drugs with known liver-injury risk. The LOI acceptance is the first step of three in the qualification process. Absentia Labs will next need to submit a qualification plan, then a full qualification package. If qualified, the AI tool will be used preclinically to support more informed decision-making before beginning Phase I testing of an experimental small molecule. -Elizabeth EatonFDA backs use of existing science to advance gene therapiesThe FDA issued draft guidance designed to help drug developers leverage existing scientific and regulatory knowledge — including chemistry, manufacturing and controls (CMC) data, non-clinical study results, and clinical information — to optimise regulatory submissions for gene therapy products using genome editing in somatic cells. The new guidance complements two existing frameworks: the plausible mechanism framework for individualised therapies and a recently issued draft on safety assessment of genome editing using next-generation sequencing. The FDA, however, clarified that sponsors must still provide scientific rationale demonstrating the applicability of leveraged data to their specific product and context.Karim Mikhail, acting director of Center for Biologics Evaluation and Research, said the latest action reflects the agency's commitment to "accelerating innovation without compromising the rigorous scientific standards that patients and the public depend on." The draft remains open to public comments for 90 days.-Pavan KamatWeight-loss drugs linked to fewer knee replacementsWeight-loss drugs may help thousands of people with knee osteoarthritis avoid or delay total knee arthroplasty (TKA), according to a large retrospective analysis published in Regional Anesthesia & Pain Medicine.Researchers analysed records from 6.8 million adults diagnosed with knee osteoarthritis between 2010 and 2024. After matching patients for comparison, cohort sizes ranged from around 13,000 on newer GLP-1s like Wegovy/Ozempic (semaglutide) or Zepbound/Mounjaro (tirzepatide) with three-year exposure, to roughly 42,000 on any GLP-1 drug and one-year exposure.GLP-1 drug use was linked to significantly lower rates of knee replacement surgery across all exposure classes, durations and follow-up intervals. After one year on any GLP-1 drug, the risk of needing a TKA fell by 2.8 percentage points over eight years (HR 0.90). The effect was stronger with newer drugs and longer use: three years on semaglutide or tirzepatide cut the risk by 4.7 percentage points, a roughly 28% reduction."These duration and agent dependent associations are consistent with potential disease modifying activity beyond weight loss alone, although prospective trials are needed to establish causality and define optimal treatment targets," the authors said (see – Physician Views Results: Practice-changing potential emerges for obese patients with hard-to-control psoriatic disease, with Lilly in driving seat).-Anna Bratulic