Senvelgo

Opinion

EMA has issued an opinion on this medicine

velagliflozin

Overview

On 5 October 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Senvelgo, intended for cats. The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

Senvelgo is a medicinal product containing velagliflozin (ATCvet code QA10BK90) as active substance, a 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 main benefit of Senvelgo is the reduction of hyperglycaemia in cats with non-insulin-dependent diabetes mellitus.

The most common side effects are diarrhoea or loose stool, polydipsia or polyuria, weight loss, dehydration and vomiting.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Senvelgo and therefore recommends the granting of the marketing authorisation.

---

¹Applicants 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.

CVMP summary of positive opinion for Senvelgo

Reference Number: EMA/CVMP/432172/2023

Product details

• Name of medicine:
  Senvelgo
• Active substance:
  Velagliflozin L-proline monohydrate
• International non-proprietary name (INN) or common name:
  velagliflozin
• Species:
  Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QA10BK90
• EMA product number:
  EMEA/V/C/005972
• Marketing authorisation applicant:
  Boehringer Ingelheim Vetmedica GmbH
• Opinion adopted:
  05/10/2023
• Opinion status:
  Positive