The US Food and Drug Administration (FDA) has granted accelerated approval to Vimkunya™, a recombinant chikungunya vaccine, for individuals aged 12 and older. The decision was based on a phase 3 clinical trial (NCT05072080), which evaluated the safety and immune response of a single intramuscular dose of Vimkunya in 2,559 participants, compared to 424 receiving a placebo.The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response starting to develop within one week. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature1. VIMKUNYA is a VLP vaccine, which means that it uses virus-like particles designed to mimic the chikungunya virus without the ability to infect cells, replicate or cause disease.
“The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,” said Paul Chaplin, President and CEO of Bavarian Nordic. “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travelers and vulnerable populations. We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.”
Concurrent with the approval, the FDA awarded Bavarian Nordic a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the Company intends to monetize when appropriate.
Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025.
The vaccine recently received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and will also be launched in key European markets in the first half of 2025, pending adoption of a final decision on the marketing authorization by the European Commission.
About chikungunya
Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years2. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years3. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5.
About VIMKUNYA™ (Chikungunya Vaccine, Recombinant)
VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older.
Additional clinical studies are required to confirm the clinical profile of VIMKUNYA, and confirmatory efficacy studies are also planned as part of the post-marketing commitments and requirements as agreed with the FDA.
VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume. read more

Ohio: Once pegged as a blockbuster medicine for lowering LDL, long-acting small interfering RNA, Inclisiran failed to find any place in the recently released American Association of Clinical Endocrinology guideline A recent American Association of Clinical Endocrinology guideline on the pharmacologic management of dyslipidemia in adults 2025 proposed that the current evidence is insufficient to establish a definitive recommendation for or against the use of Inclisiran to reduce the risk of atherosclerotic cardiovascular disease (ASCVD).The guidelines published in the Endocrine Practice highlighted that only a few clinical trials have been conducted, and the available data on cardiovascular events is too limited to determine whether inclisiran provides significant benefits or poses any risks when added to standard care.Inclisiran, a small interfering RNA therapy, has demonstrated a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels and has been approved by the USFDA since 2021 and by the Indian CDSCO since 2023. Inclisiran is a long-acting, synthetic small interfering RNA (siRNA) directed against proprotein convertase subtilisin-kexin type 9 (PCSK9), which is a serine protease that regulates plasma low-density lipoprotein cholesterol (LDL-C) levels. By binding to PCSK9 messenger RNA, inclisiran prevents protein translation of PCSK9, leading to decreased concentrations of PCSK9 and plasma concentrations of LDL cholesterol. However, its impact on cardiovascular outcomes remains uncertain due to lack of well-powered, long-term studies. While all evaluated lipid-lowering medications effectively reduce LDL-C, their impact on mortality and cardiovascular events remains unclear. Consequently, the guidelines issue conditional recommendations for the use of alirocumab, evolocumab, and bempedoic acid in adults with or at increased risk for ASCVD.Ongoing large-scale clinical trials, including ORION-4 (NCT03705234) and VICTORION-2 PREVENT (NCT05030428), are expected to provide additional insights upon completion in 2026 and 2027, respectively. These trials aim to evaluate inclisiran’s effects on urgent coronary revascularization and all-cause mortality, with VICTORION-2 PREVENT also assessing major limb adverse events—a clinically significant factor in treatment decision-making.
A systematic review of randomized controlled trials (RCTs) evaluating the efficacy of inclisiran in adults with dyslipidemia indicates that the drug does not provide a statistically significant reduction in major cardiovascular events over a follow-up period of 30 to 77 weeks. Across a sample size ranging from 3,655 to 3,739 participants, inclisiran demonstrated no clinically meaningful effect on all-cause mortality (OR 1.01, 95% CI 0.59-1.71), cardiovascular-related mortality (OR 1.11, 95% CI 0.56-2.23), stroke (OR 0.69, 95% CI 0.11-4.21), or myocardial infarction (OR 0.85, 95% CI 0.36-1.98). Additionally, the likelihood of treatment discontinuation due to adverse events was slightly higher in the inclisiran cohort (OR 1.21, 95% CI 0.77-1.88), though this finding was not statistically significant. The certainty of evidence for all reported outcomes was rated as low, highlighting potential bias and imprecision in effect estimates. Furthermore, data on coronary revascularization and peripheral vascular disease (PVD) events were unavailable in the reviewed studies.
The guidelines do not demonstrate clinically meaningful benefits of inclisiran in reducing mortality or cardiovascular events when added to usual care. While minor absolute risk reductions were observed—such as three fewer strokes and myocardial infarctions per 1,000 participants—these effects fall within confidence intervals that include potential harms. Similarly, no significant difference was observed in all-cause and cardiovascular-related mortality rates. Adverse events, primarily injection site reactions and bronchitis, led to a small number of treatment discontinuations, though these were considered trivial. Given these findings, inclisiran’s net clinical benefit remains uncertain, with its effects deemed marginal by expert reviewers.
Due to limited clinical evidence, it remains unclear whether inclisiran’s potential cardiovascular and mortality benefits outweigh possible risks when used alongside usual care. To address these uncertainties, robust, long-term cardiovascular outcomes trials are needed to assess its efficacy in reducing cardiovascular events, its impact on mortality, and its long-term safety profile.
A discussion published in the Endocrinology and Metabolism Institute noted that inclisiran was not included in the 2017 AACE guidelines (like not FDA approved then) and, as of 2025, remains without a recommendation due to insufficient evidence for relevant clinical outcomes of interest.
The guidelines also recommend pharmacotherapy to reduce the risk of atherosclerotic cardiovascular disease events. It highlights several effective and safe treatment options for adults with dyslipidemia, particularly those with ASCVDor at increased risk, who require additional lipid-lowering medications.
Reference:
Patel SB, Wyne KL, Afreen S, Belalcazar LM, Bird MD, Coles S, Marrs JC, Peng CC, Pulipati VP, Sultan S, Zilbermint M. American Association of Clinical Endocrinology Clinical Practice Guideline on Pharmacologic Management of Adults With Dyslipidemia. Endocr Pract. 2025 Feb;31(2):236-262. Correa R. Highlights of the 2025 American Association of Clinical Endocrinology Clinical Practice Guideline on Pharmacologic Management of Adults With Dyslipidemia. Endocr Pract. 2024 Dec 18:S1530-891X(24)00831-0. doi: 10.1016/j.eprac.2024.11.006. Epub ahead of print. PMID: 39918518.Inclisiran, International Innovator Prescribing Information, Leqvia, Last Revised June,2024: URL: https://www.leqviohcp.com/dosing-and-administration   read more

Researchers have found in a new study that SGLT2 inhibitors may have disease-modifying effects in nonsevere aortic stenosis (AS). After adjustments, patients taking these inhibitors had a significantly lower risk of progressing to severe aortic stenosis. This marks a potential breakthrough, as effective medical therapy for AS has remained elusive until now.Aortic stenosis (AS) is the leading cause of valvular heart disease-related morbidity and mortality, but there are no medical treatments to slow its progression. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have pleiotropic effects which could be disease modifying in aortic stenosis. A target trial emulation comparing the effect of the initiation of SGLT2i with no SGLT2i in patients with nonsevere aortic stenosis was performed using retrospective electronic medical record data from the Yale New Haven Health System from January 2016 to September 2022. Patients with native aortic valve sclerosis or nonsevere aortic stenosis with at least 12 months of echocardiographic follow-up were included. Patients were excluded if they had an estimated glomerular filtration rate <30 mL/min/1.73 m2 or had initiated SGLT2i >1 year before the index echocardiogram. The prespecified primary outcome was progression to severe aortic stenosis. Results: 458 patients prescribed SGLT2i and 11,240 patients never prescribed SGLT2i were included. Patients were on SGLT2i for a median of 0.9 years. Patients on SGLT2i were younger and had higher rates of diabetes and chronic kidney disease. Patients on SGLT2i were more likely to have ejection fraction ≤40%. There were no differences between groups in baseline AS severity (66% sclerosis, 23% mild stenosis, and 11% moderate in overall cohort). Patients ever prescribed SGLT2i were less likely to progress to severe aortic stenosis (HR: 0.61; 95% CI: 0.39-0.94; P = 0.03) with a progressively lower risk among patients on SGLT2i for >3, 6, and 12 months (HR: 0.54, 0.48, and 0.27, respectively). This retrospective, multicenter, observational study suggests that SGLT2i may slow the progression of nonsevere aortic stenosis.Reference:Shah, T, Zhang, Z, Shah, H. et al. Effect of Sodium-Glucose Cotransporter-2 Inhibitors on the Progression of Aortic Stenosis. J Am Coll Cardiol Intv. null2025, 0 (0) .https://doi.org/10.1016/j.jcin.2024.11.036Keywords:SGLT2 Inhibitors, exhibit, Potential, Slowing, Aortic, Stenosis, Progression, study, Shah, T, Zhang, Z, Shah, H read more