Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026

CVMP Meeting Highlights Key Regulatory Decisions for Veterinary Medicines

The European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) convened from June 16-18, 2026, issuing several key opinions and updates. A negative opinion was adopted for a marketing authorisation for Scovella (velagliflozin) for hyperinsulinaemia in horses, classified for a limited market. Conversely, positive opinions were granted for Nobivac NXT HCPChFeLV, Nobivac NXT FeLV, and Nobivac NXT HCPFeLV for active immunisation in cats against various viral infections. The CVMP also extended the marketing authorisation for Innovax ND-H5, an avian influenza vaccine, under exceptional circumstances. Additionally, the committee adopted scientific advice reports, classified a product for dogs for a limited market, and released concept papers for public consultation on guidelines for immunological veterinary medicinal products and pharmacovigilance.

• The CVMP issued a negative opinion for Scovella (velagliflozin), intended for the treatment of hyperinsulinaemia and associated clinical signs in insulin-dysregulated horses and ponies, due to its classification as a product for a limited market. In contrast, the Committee adopted positive opinions for several Nobivac NXT vaccines (HCPChFeLV, FeLV, HCPFeLV) for active immunisation of cats against various infections including feline herpesvirus, calicivirus, panleucopenia virus, and leukaemia virus. Furthermore, the marketing authorisation for Innovax ND-H5, an avian influenza vaccine, was extended for one year under exceptional circumstances.
• The Committee adopted two significant concept papers for public consultation, each for a 3-month period. One paper proposes a revision of the Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021), aiming to enhance clarity and ensure consistent interpretation. The second concept paper focuses on updating and streamlining the Guideline on data requirements for the replacement of established master seeds (EMEA/CVMP/IWP/105504/2007) and integrating it with a reflection paper (EMA/CVMP/IWP/37620/2014) to align with current legislation.
• The CVMP adopted updated standard lists and associated documents for the electronic reporting of suspected adverse reactions, including the combined VeDDRA list of clinical terms. The implementation of the standard VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for October 1, 2026. Additionally, the Committee adopted a document providing an overview of its activities related to antimicrobials, outlining a status report from 2021-2025 and detailing ongoing and planned strategic activities in line with EMANS 2028 and the 'One Health' approach.

Addressing Challenges in Equine Hyperinsulinaemia Treatment

Managing hyperinsulinaemia and its sequelae in insulin-dysregulated (ID) horses and ponies is complicated by a convergence of pathophysiological, pharmacological, and practical barriers. The speed with which severe hyperinsulinaemia can precipitate laminitis — with healthy Standardbred horses developing clinical signs within 48 hours of prolonged hyperinsulinaemic challenge — underscores the urgency of identifying effective and broadly applicable therapeutic strategies.

• Limited applicability of first-line interventions: Weight loss and increased exercise remain the mainstays of treatment for obese insulin-resistant horses, yet these approaches are inappropriate for non-obese insulin-resistant animals or those in which exercise is contraindicated due to active laminitis or other clinical conditions — significantly narrowing the eligible treatment population.

• Owner compliance: Dietary restriction and exercise programmes require sustained owner adherence, and poor compliance represents a meaningful real-world barrier to achieving durable improvements in insulin sensitivity.

• Pharmacological risks from routine medications: Alpha-2 agonists present a clinically significant challenge; in ID horses, xylazine administration has been associated with severe rebound hyperinsulinaemia, whereas detomidine did not produce this effect (P = 0.02), necessitating careful sedation selection. Corticosteroid use carries well-documented risks, including corticosteroid-induced laminitis and a reported correlation between intra-articular corticosteroid administration and laminitis onset. Notably, intra-articular methylprednisolone acetate (MPA) requires further investigation in ID and laminitis-prone horses before it can be considered safe, despite demonstrating no significant effect on insulin or glucose in metabolically normal horses.

• Dietary carbohydrate thresholds incompletely defined — and protein thresholds absent: While thresholds for hydrolysable carbohydrate consumption have recently been proposed to minimise postprandial insulin response, equivalent thresholds for dietary protein have not yet been established. Horses with ID exhibit pronounced hyperinsulinaemic responses following consumption of feeds across a range of protein, non-structural carbohydrate, starch, and water-soluble carbohydrate intakes, highlighting a critical gap in nutritional management guidelines.

• Chronic dietary patterns may perpetuate insulin resistance: Grain-based concentrate feeds elicit postprandial hyperinsulinaemia, and repeated chronic exposure is associated with the development of insulin resistance. Experimental severe hyperinsulinaemia (>1,000 mIU/L during 6-hour insulin infusion) has further been shown to downregulate glucose transporter 4, glucose transporter 1, and insulin receptor transcript abundance in adipose tissue, and reduce insulin receptor protein abundance in skeletal muscle — suggesting that hyperinsulinaemia itself can reinforce an insulin-resistant state.

• Poorly understood pathophysiology: The precise molecular mechanisms underlying equine metabolic syndrome (EMS) remain incompletely characterised, and the role of gastrointestinal factors — including incretin hormones such as GLP-1 — in the pathogenesis of ID and hyperinsulinaemia is poorly understood relative to other species, limiting the rational translation of mechanistic therapeutic targets.

• Insufficient evidence for alternative therapeutic modalities: Despite showing promise in humans and laboratory animals, the effects of herbal compounds acting via pathways such as peroxisome proliferator-activated receptor activation, carbohydrate absorption inhibition, and insulin receptor activation remain poorly characterised in horses. Similarly, the effects of insulin dysregulation on protein metabolism in equids remain largely unexplored, representing a substantive gap in the broader understanding of the condition.

Scovella's Safety Profile and Regulatory Setback

Across its studied indications in veterinary medicine, velagliflozin has demonstrated a consistently favorable safety and tolerability profile. In two key studies conducted in insulin-dysregulated ponies, velagliflozin administered orally at 0.3 mg/kg body weight once daily was well accepted by all subjects and produced no adverse effects, hypoglycemic events, or clinically significant findings throughout the treatment period. Safety assessments encompassing daily monitoring, veterinary examinations, and serial measurements of fasting blood glucose, biochemistry, and haematology revealed no concerning signals. Importantly, no deaths or discontinuations due to adverse events were reported in either study. The primary limitation acknowledged across this body of evidence was the relatively small sample size of the investigations.

Longer-term tolerability was further supported by withdrawal data from the 16-week equine study, in which insulin concentrations returned to baseline levels following a four-week cessation period with no observed rebound effect — a clinically relevant finding that speaks to the reversibility of the drug's pharmacodynamic action. These results position velagliflozin as a promising and well-tolerated therapeutic option for equine insulin dysregulation and laminitis prevention. Emerging feline data from a 2026 case series involving seven diabetic cats considered non-ideal candidates for SGLT2 inhibitor therapy adds a preliminary signal of utility in a broader patient population, with ketone monitoring in urine and blood identified as a valuable tool for tracking metabolic changes and informing safety surveillance in this species.

Evolution of Hyperinsulinaemia Treatment Landscape

Over the past five years, the treatment landscape for hyperinsulinaemia and endocrinopathic laminitis in insulin-dysregulated (ID) equids has been substantially reshaped by clinical trial data supporting sodium-glucose cotransporter-2 (SGLT2) inhibitors as a meaningful pharmacological intervention. Canagliflozin emerged as an early proof-of-concept agent: in a case series of ten horses with hyperinsulinaemia refractory to diet control, metformin, levothyroxine, and pergolide, once-daily oral administration produced normalisation or near-normalisation of serum insulin concentrations in all animals, with complete resolution of laminitis pain and regression of abnormal fat deposits. A subsequent randomised, double-blind, placebo-controlled trial of canagliflozin (0.6 mg/kg PO q24h) in 16 privately-owned ID horses demonstrated a greater than 66% reduction in insulin AUC during an oral sugar test (OST) compared with placebo, alongside an 11.1 kg reduction in body weight, though transient hypertriglyceridaemia was observed. Velagliflozin, a second SGLT2 inhibitor, was evaluated in a 37-horse randomised controlled trial over 20 weeks; resting insulin concentrations were significantly lower in the velagliflozin group (71 [33–131] μIU/mL) versus placebo (157 [82–298] μIU/mL; p < 0.0001), with a median 1-point reduction in body condition score (p = 0.02) and a transient, clinically uneventful rise in serum triglycerides. Collectively, these data position SGLT2 inhibitors — particularly for refractory cases — as the most clinically substantiated pharmacological advance in equine ID management of the past five years.

Mechanistic investigations have simultaneously expanded the therapeutic target space. A 2023 study in five ponies demonstrated that intravenous administration of the GLP-1 receptor antagonist Exendin-3 (9-39) amide (80 µg/kg) significantly reduced the insulin AUC (p = 0.04) following a high-starch, high-glycaemic index diet, establishing an incretin-mediated component to postprandial hyperinsulinaemia in ID equids and identifying the GLP-1 axis as a potential future target. Separately, a pharmacokinetic and pharmacodynamic investigation of sirolimus, a mechanistic target of rapamycin (mTOR) inhibitor, in eight Standardbred geldings showed that a single dose reduced insulin concentrations at 60 min (37% lower than placebo; p = 0.03) and 120 min (28% lower; p = 0.02) post-administration, with minimal effect on glucose, though insulin responses attenuated after seven days of dexamethasone-induced ID. At the molecular level, exogenous FBXW7 protein has been shown to markedly reduce Fetuin-A expression in liver and adipose tissue biopsies from obese horses, restoring insulin receptor phosphorylation via downregulation of the TLR4/NF-κB/MAPK pathway, representing a novel mechanistic pathway with potential therapeutic relevance. Additionally, nutraceutical supplementation in a placebo-controlled trial of 16 mature ID horses produced 61% greater glucose clearance rates (p = 0.05), with significantly lower insulin concentrations at 75 minutes post-challenge (p = 0.003).

Refinements in dietary and exercise management have also been informed by recent trial data. Studies have confirmed that ID horses exhibit an exaggerated postprandial incretin response to feeds spanning a range of protein, non-structural carbohydrate (NSC), starch, and water-soluble carbohydrate intakes, with proposed thresholds for both carbohydrate and protein consumption to minimise postprandial insulinaemia. A 2026 trial demonstrated that oligosaccharide supplementation significantly reduced insulin in geldings with Equine Metabolic Syndrome (p = 0.02), with sex identified as a modifying factor. Training combined with aleurone supplementation (200 g/day) in Standardbred mares produced improvements in glucose metabolism beyond training alone, including reduced acute insulin response to glucose (AIRg; p = 0.030) and increased glucose effectiveness (Sg; p = 0.031), with associated microbiome shifts including reductions in inflammation-associated Desulfovibrio. Importantly, an observational study of 804 UK horse owners found that exercise-related variables correlated inversely with laminitis and Equine Metabolic Syndrome prevalence, yet approximately 90% of respondents reported substantial barriers outside their control limiting human-led exercise — underscoring that foundational management strategies, including dietary NSC restriction, exercise when feasible, and appropriate treatment of concurrent pituitary pars intermedia dysfunction (PPID), remain the non-negotiable core of any treatment protocol.

Velagliflozin's Equine Roadblock: A Regulatory Conundrum

The recent negative opinion from the European Medicines Agency's CVMP regarding Scovella (velagliflozin) for hyperinsulinaemia in horses presents a fascinating case study in veterinary pharmaceutical development. Velagliflozin, an SGLT2 inhibitor, has already carved out a significant niche in feline medicine, being the first oral liquid medication approved by the FDA for diabetes in cats. Research indicates its effectiveness in improving glycemic control, reducing insulin doses, and even allowing insulin discontinuation in some feline patients, including those with complex comorbidities like hypersomatotropism. This success underscores the therapeutic potential of the SGLT2 inhibitor class in managing metabolic disorders across species.

However, the path to approval for horses appears more challenging. Studies in insulin-dysregulated ponies demonstrated that velagliflozin significantly reduced hyperinsulinemia and effectively prevented laminitis, a severe and common complication, without causing hypoglycemia or other significant adverse effects. These findings were particularly noteworthy given the current lack of registered veterinary drugs for this specific equine condition, highlighting a clear unmet medical need.

The CVMP's negative opinion, despite these promising results and the 'limited market' classification, suggests that the submitted data likely fell short of regulatory requirements. A key risk identified in earlier pony studies was the sample size, which may have contributed to the committee's decision. Furthermore, while generally well-tolerated, the SGLT2 inhibitor class is associated with the risk of euglycemic diabetic ketoacidosis (eDKA) in other species, a serious complication that regulators would scrutinize closely for any new indication. This decision underscores the critical importance of robust, adequately powered clinical trials and comprehensive safety data tailored to each target species. For the company, this necessitates a strategic re-evaluation of its equine development program, potentially focusing on strengthening its already successful feline diabetes franchise while considering the significant investment required to overcome regulatory hurdles for horses. Meanwhile, the equine health community continues to await an approved therapeutic option for insulin dysregulation, leaving the door open for other innovators.