Ingelheim am Rhein, Germany, November 10, 2026
Boehringer Ingelheim has announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has adopted a positive opinion recommending marketing authorization for SCOVELLA® (velagliflozin oral solution) in the European Union. The investigational regulatory milestone is significant for equine health because SCOVELLA is intended to reduce hyperinsulinaemia and the associated risk of laminitis in horses with Equine Metabolic Syndrome (EMS) that do not respond adequately to changes in husbandry and exercise. If the European Commission grants final marketing authorization, SCOVELLA would become the first veterinary medicine approved in the EU for this specific indication and the first SGLT-2 inhibitor authorized for horses in the region. The recommendation follows a re-examination of the product’s earlier regulatory assessment and represents an important development in veterinary pharmaceutical research. The company highlighted the treatment’s potential to address a major unmet need in equine medicine, particularly for horses affected by insulin dysregulation and at risk of developing painful hoof disease.
SCOVELLA Targets Hyperinsulinaemia in Horses
Equine Metabolic Syndrome (EMS) is a complex metabolic condition characterized by insulin dysregulation, abnormal fat distribution and an increased susceptibility to laminitis. Hyperinsulinaemia, a condition involving persistently elevated insulin concentrations in the blood, is considered a major risk factor for endocrinopathic laminitis. Laminitis is a painful inflammatory condition affecting the sensitive tissues connecting the hoof wall to the underlying structures of the horse’s foot. Severe or recurring episodes can result in substantial pain, impaired mobility and long-term disability. Boehringer Ingelheim estimates that approximately one in five horses is affected by insulin dysregulation, which is associated with a substantial proportion of laminitis cases. The company developed SCOVELLA to address elevated insulin levels, a key biological driver of this complication. The proposed indication specifically covers horses with EMS that have not responded adequately to changes in their management and exercise routines. The medicine is intended to complement appropriate veterinary care and management rather than replace dietary adjustments, exercise and regular monitoring. This is particularly relevant because controlling insulin dysregulation is an important part of reducing the risk of recurrent laminitis in susceptible horses.
Velagliflozin Uses an SGLT-2 Inhibitor Mechanism
The active ingredient in SCOVELLA is velagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT-2). This protein plays an important role in glucose reabsorption in the kidneys. By inhibiting SGLT-2, velagliflozin reduces the amount of glucose reabsorbed into the bloodstream, allowing more glucose to be eliminated through urine. This mechanism helps lower blood glucose levels and subsequently reduce excessive insulin concentrations. The product is formulated as an oral liquid medication, providing a route of administration suitable for horses. According to Boehringer Ingelheim, SCOVELLA represents the result of approximately 15 years of research and development focused on improving equine metabolic health. Its development reflects growing interest in applying targeted metabolic pharmacology to veterinary conditions that previously relied heavily on management-based interventions. The product was approved and introduced in Great Britain earlier in 2026. The proposed EU authorization would extend its regulatory availability to another important veterinary medicine market. As with other SGLT-2 inhibitors, veterinary supervision and monitoring remain important, and treatment decisions should consider the individual horse’s metabolic condition and overall health.
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Positive CVMP Opinion Marks Regulatory Milestone
The positive CVMP opinion followed a re-examination of an earlier negative opinion adopted in June 2026. Following the review, the committee recommended authorization under the limited market framework established by European veterinary medicines legislation. According to the European Medicines Agency, SCOVELLA is the first veterinary medicinal product recommended under this framework since the relevant regulatory provisions came into effect in 2022. This framework allows tailored documentation requirements for products intended for limited markets, provided the benefit-risk assessment is favourable. The recommended indication is specifically for reducing hyperinsulinaemia and the associated risk of laminitis in horses with EMS that do not respond to changes in husbandry and exercise. The CVMP recommendation is an important regulatory step, but final marketing authorization must still be granted by the European Commission. Once authorized, SCOVELLA could provide veterinarians and horse owners with a new pharmacological option for managing insulin dysregulation and reducing associated laminitis risk. The development also highlights the importance of veterinary pharmaceutical innovation in addressing chronic metabolic diseases and improving animal welfare.
Source: Boehringer Ingelheim press release
