Scovella

Opinion

EMA has issued an opinion on this medicine

velagliflozin

Overview

On 18 June 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a negative opinion, recommending the refusal of the granting of a marketing authorisation for the veterinary medicinal product 'Scovella 15 mg/ml oral solution'.

At the time of submission, the applicant applied for the following indication: "For the treatment of hyperinsulinaemia and associated clinical signs (e.g. laminitis) in insulin-dysregulated horses and ponies not responsive to changes in husbandry and exercise regimen".

The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

The active substance of Scovella is velagliflozin, a 'glucoside sodium-dependent glucose co-transporter 2' (SGLT-2) inhibitor. Inhibition of SGLT-2 decreases renal glucose reabsorption, which reduces blood glucose levels and thus allows for the control of hyperglycaemia.

The grounds for the negative opinion relate to the following points:

• Efficacy
• Target animal safety

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit to risk balance for Scovella was not demonstrated to be favourable and therefore cannot recommend the granting of a marketing authorisation.

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Note: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Product details

• Name of medicine:
  Scovella
• Active substance:
  velagliflozin
• International non-proprietary name (INN) or common name:
  velagliflozin
• Species:
  Horses
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QA10BK90
• EMA product number:
  EMEA/V/C/006610
• Marketing authorisation applicant:
  Boehringer Ingelheim Vetmedica GmbH
• Opinion adopted:
  18/06/2026
• Opinion status:
  Negative