The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has recommended granting a marketing authorisation for Scovella (velagliflozin), marking the first positive recommendation for a veterinary medicinal product under the European Union’s limited market regulatory framework established by Regulation (EU) 2019/6. The positive opinion was adopted on 5 November 2026 following a re-examination of the Committee’s negative opinion issued in June. The applicant is Boehringer Ingelheim Vetmedica GmbH.
Indication and therapeutic use
Scovella is a 15 mg/ml oral solution intended for non-food-producing horses. According to the EMA, it is intended to reduce hyperinsulinaemia and the associated risk of laminitis in horses with Equine Metabolic Syndrome (EMS) whose condition has not responded to changes in husbandry and exercise.
Laminitis is a painful and potentially debilitating condition affecting the horse’s hooves. In horses with EMS, excessive insulin levels are associated with an increased risk of developing this condition.
Mechanism of action and safety profile
The active substance, velagliflozin, is a sodium-glucose cotransporter 2 (SGLT-2) inhibitor (ATCvet code QA10BK90). By inhibiting SGLT-2 in the kidneys, the substance reduces glucose reabsorption and increases urinary glucose excretion. This lowers blood glucose levels and helps control hyperglycaemia.
The EMA identifies the following as the most common adverse effects:
- elevated triglycerides
- elevated liver enzymes
- elevated cholesterol
- lipaemia
- elevated blood urea nitrogen (BUN)
Following its assessment of the submitted quality, safety and efficacy data, the CVMP concluded that Scovella has a favourable benefit-risk balance and recommended granting a marketing authorisation.
First positive recommendation under the limited market framework
The recommendation is a significant development in the implementation of Regulation (EU) 2019/6, which became applicable on 28 January 2022. Article 23 establishes a specific authorisation pathway for veterinary medicinal products intended for limited markets.
Under Article 23 of Regulation (EU) 2019/6, applicants for veterinary medicinal products intended for limited markets may be exempted from submitting comprehensive safety or efficacy documentation under Article 8(1)(b) and Annex II, provided they demonstrate that the benefits of making the product available outweigh the risks associated with the missing data and that the product meets the limited-market definition in Article 4(29). The derogation does not extend to general quality requirements.
The EMA describes Scovella as the first veterinary medicinal product recommended by the CVMP under this framework since Regulation (EU) 2019/6 came into effect. The recommendation should not be confused with a marketing authorisation: the European Commission must still adopt the formal decision.
Next regulatory steps
The CVMP’s positive opinion will be followed by consideration by the European Commission, which is responsible for granting the marketing authorisation. The detailed conditions of use, including dosage, warnings and precautions, will be published in the Summary of Product Characteristics (SPC) and made available through the Union Product Database (UPD) after the marketing authorisation has been granted.
Primary sources
- European Medicines Agency (EMA), 6 November 2026: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP), 3–5 November 2026.
- European Medicines Agency (EMA): Scovella — European Public Assessment Report (EPAR), updated 6 November 2026.
- Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products.
