EMA CVMP Issues Negative Opinion on Boehringer Ingelheim's Scovella (Belagliflozin), an SGLT2 Inhibitor for Horses
Background of the CVMP Negative Opinion
The European Medicines Agency (EMA)'s Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion regarding Scovella (Belagliflozin 15 mg/ml oral solution) from Boehringer Ingelheim Vetmedica during its meeting on June 16-18, 2026. Scovella was intended for the treatment of insulin dysregulation and related clinical signs (e.g., laminitis) in horses and ponies that do not respond to dietary and exercise management. The CVMP determined that the submitted clinical data did not sufficiently demonstrate safety and efficacy, and it failed to meet the requirements for approval, even though it was classified as a 'limited market product'.
Clinical Evidence and Limitations of Belagliflozin
Belagliflozin is an SGLT2 (sodium-glucose cotransporter 2) inhibitor that works by blocking glucose reabsorption in the proximal renal tubule, inducing glucosuria and lowering blood insulin levels. In a double-blind, randomized, controlled clinical trial (n=37, 0.3 mg/kg once daily orally, 20 weeks + 20 weeks open label), no cases of laminitis were observed in the belagliflozin group, while 14 out of 37 horses in the control group developed Obel grade 1-2 laminitis. Although no serious adverse events such as hypoglycemia were reported, hypertriglyceridemia was observed in some cases, suggesting that long-term safety data may be insufficient.
Boehringer Ingelheim Pipeline Context
Boehringer Ingelheim (unlisted, headquartered in Ingelheim, Germany) has already commercialized the same active ingredient, belagliflozin, as Senvelgo for feline diabetes and received simultaneous EU and US FDA approval in 2023. The company's Animal Health division recorded sales of EUR 2.6 billion in the first half of 2025 (up 7.6% year-on-year) and is expanding its portfolio, primarily focused on NexGard. SGLT2 inhibitors for horses are still an untapped area, as no products have been officially approved worldwide, and the rejection of Scovella means that entry into this market will be delayed.
Competitive Landscape and Market Outlook
Currently, canagliflozin (Johnson & Johnson's Invokana) and ertugliflozin (Merck/Pfizer's Steglatro) are used off-label for insulin dysregulation in horses, distributed through prescriptions for human use. The global equine veterinary medicine market is estimated at approximately USD 1.6 billion in 2025 and is expected to grow by 6.8-7.5% per year, but there are no drugs specifically approved for insulin dysregulation. Boehringer Ingelheim may submit additional data and request a re-examination, but this could take 1-2 years, so off-label SGLT2 inhibitors are likely to remain the standard of care for the time being.
Boehringer Ingelheim aimed to expand its successful Senvelgo (belagliflozin) for cats, approved in the EU and US in 2023, to horses and ponies. However, the CVMP's negative opinion has thwarted its entry into the European market, delaying the timeline for the first approval of an SGLT2 inhibitor for horses by at least 1-2 years. In the global equine veterinary medicine market (approximately USD 1.6 billion in 2025), the lack of approved drugs specifically for insulin dysregulation will persist, and veterinarians will continue to rely on the off-label use of human drugs such as canagliflozin and ertugliflozin. While there is no direct impact on the stock price of Boehringer Ingelheim, which is an unlisted company, the delay in expanding its horse portfolio is a negative signal for its Animal Health division (EUR 2.6 billion in sales in the first half of 2025). The key monitoring points in the future will be whether Boehringer Ingelheim can strengthen its long-term safety data and when it will request a re-examination.