CVMP adopts a positive opinion for SCOVELLA®, the first therapy for hyperinsulinaemia in horses with

• SCOVELLA® was developed to reduce hyperinsulinaemia in insulin-dysregulated horses, a key underlying driver of laminitis – a common, painful inflammatory condition in horses' hooves and significant unmet need in equine health.  
• Laminitis is one of the most significant causes of pain and disability in horses, with one-third of affected horses euthanized within a year of diagnosis.1 
• Once the European Commission follows the CVMP recommendation and grants a marketing authorization, SCOVELLA® would be the first therapy approved in the European Union for the reduction of hyperinsulinaemia and the reduction of associated risk of laminitis in horses with Equine Metabolic Syndrome.2 

Ingelheim, Germany - Boehringer Ingelheim, a global leader in animal health, announced that the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) has adopted a positive opinion for SCOVELLA® (velagliflozin oral solution), recommending marketing authorization in the European Union (EU). 

“The CVMP's positive opinion for SCOVELLA® recognizes the significant need for new treatments for hyperinsulinaemia, a key underlying driver of laminitis in horses," said Saskia Kley, Global Head of Equine at Boehringer Ingelheim. “With this opinion, owners of horses with Equine Metabolic Syndrome in the EU are one step closer to a breakthrough innovation to reduce hyperinsulinaemia and reduce the associated risk of laminitis, one of the most devastating conditions in equine health.”

Equine Metabolic Syndrome is a collection of metabolic and clinical features that include insulin dysregulation (ID) as a core component, resulting in an increased risk of laminitis in horses.3

Laminitis is a common and painful inflammatory condition of horses' hooves and one of the most significant causes of pain and disability in horses, with one-third of affected horses euthanized within a year of diagnosis.1 Affecting an estimated one in five horses, insulin dysregulation is estimated to be associated with more than 90% of laminitis cases.4

Once SCOVELLA® is approved by the European Commission, it would be the first SGLT-2 inhibitor authorized for horses in the European Union. SCOVELLA® was approved and introduced in Great Britain earlier this year.  

With 15 years of research behind SCOVELLA®, the SGLT-2 inhibitor is an example of Boehringer Ingelheim's commitment to advance equine health innovations in areas of high unmet need. The oral liquid medication is designed to inhibit glucose reabsorption in the kidneys, leading to a rapid and sustained reduction of insulin to address the main cause of laminitis. 

About Boehringer Ingelheim – Animal Health business  
Boehringer Ingelheim provides innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at www.boehringer-ingelheim.com/animal-health.   

About Boehringer Ingelheim  
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective. Our approximately 54,300 employees serve over 130 markets to build a healthier tomorrow. Learn more at www.boehringer-ingelheim.com.  

 References:  

1 Luthersson, N., Mannfalk, M., Parkin, T. D., & Harris, P. (2017). Laminitis: risk factors and outcome in a group of Danish horses. Journal of Equine Veterinary Science, 53, 68-73. 
2 Proposed indication: For the reduction of hyperinsulinaemia and reduction of associated risk of laminitis in horses with Equine Metabolic Syndrome not responsive to changes in husbandry and exercise regimen. See the CVMP summary of positive opinion.
3 Bertin, F. R., Bailey, S., Burns, T., De Laat, M., Durham, A. E., Frank, N., ... & Menzies-Gow, N. J. (2024). Recommendations for the diagnosis and management of equine metabolic syndrome (EMS) and insulin dysregulation. Equine Endocrinology Group. 
4 Karikoski, N. P., Horn, I., McGowan, T. W., & McGowan, C. M. (2011). The prevalence of endocrinopathic laminitis among horses presented for laminitis at a first-opinion/referral equine hospital. Domestic animal endocrinology, 41(3), 111-117.