Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026

CVMP Approves Bexatil, Addresses Vetmedin Referral, and Updates Guidelines

The Committee for Veterinary Medicinal Products (CVMP) convened from 14-16 July 2026, delivering several key regulatory outcomes. A positive opinion was adopted for the marketing authorisation of Bexatil, intended for the reduction of hyperglycaemia in cats with diabetes mellitus not previously treated with insulin. The Committee also issued positive opinions for variations to Mometamax Ultra and Cimalgex, updating their respective adverse event profiles. Furthermore, a referral procedure was initiated for Vetmedin 1.5 mg/ml oral solution for dogs, stemming from a lack of consensus among Member States regarding a new indication. The CVMP also adopted scientific advice reports, classified a product for limited market, and advanced several concept papers and revised guidelines for public consultation or implementation.

• The CVMP adopted a positive opinion for the marketing authorisation of Bexatil, a new veterinary medicinal product designed to reduce hyperglycaemia in cats suffering from diabetes mellitus who have not previously received insulin treatment. Additionally, positive opinions were issued for variations to Mometamax Ultra and Cimalgex, which updated their safety information to include new 'very rare' adverse events such as deafness for Mometamax Ultra, and changed the frequency of renal issues for Cimalgex from 'very rare' to 'rare'.
• A significant development was the initiation of a referral procedure for Vetmedin 1.5 mg/ml oral solution for dogs, a product from Boehringer Ingelheim Vetmedica GmbH. This action was taken by the European Commission under Article 54(8) of Regulation (EU) 2019/6, due to a lack of consensus among Member States within the CMDv’s review process regarding a variation to add a new indication, specifically on the grounds of efficacy.
• The Committee also focused on regulatory guidance, adopting several concept papers for public consultation, including a revision of the guideline on pharmaceutical fixed combination products and a new concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies. Moreover, revised guidelines concerning data requirements for changes to influenza vaccine strain composition and in-use stability claims for veterinary vaccines were adopted, with an effective date of 16 January 2027, following administrative updates to align with Regulation (EU) 2019/6.

Addressing Unmet Needs in Feline Diabetes Management

Recent literature highlights a growing focus on diabetic cats whose clinical profiles fall outside the strict eligibility criteria typically used in pivotal SGLT2 inhibitor studies. This shift reflects an unmet need for guidance on managing complex, comorbid feline diabetes cases in real-world referral settings.

• A 2026 retrospective case series from the Small Animal Department at Ghent University (initial consultations spanning March 2024–May 2025) examined seven diabetic cats treated with velagliflozin (Senvelgo; Boehringer Ingelheim) who were considered non-ideal candidates for this SGLT2 inhibitor therapy.

• Target populations of interest included diabetic cats with suspected or confirmed comorbidities that complicate standard diabetes management, notably hypersomatotropism and chronic kidney disease.

• The series captured real-world complexity by documenting concurrent use of other therapies, including cabergoline and insulin, alongside velagliflozin.

• Four cats were monitored via continuous glucose monitoring to support individualized dosing and optimize glycemic control, while urine and/or blood ketone concentrations were tracked to characterize treatment-associated metabolic changes.

• The authors note that in these non-ideal cases, velagliflozin use may constitute off-label administration, requiring adherence to local ethical/legal regulations and informed client consent.

• A key unmet need identified is the scarcity of data on SGLT2 inhibitor use outside highly selected populations, as most existing feline studies apply strict exclusion criteria that limit generalizability to complicated, comorbid patients seen in routine referral practice.

Evolution of Feline Diabetes Treatment Landscape

The most significant evolution in managing insulin-naive feline diabetes mellitus has been the clinical evaluation of the sodium-glucose cotransporter 2 (SGLT2) inhibitor, bexagliflozin, as an oral monotherapy. A pivotal 2023 prospective open-label trial (NCT04793165) enrolled 84 client-owned, previously untreated diabetic cats, administering bexagliflozin at 15 mg once daily. The primary efficacy endpoint, defined as a reduction in hyperglycemia and improvement of associated clinical signs by day 56, was achieved by 84.0% of evaluable cats. This clinical success was substantiated by statistically significant decreases in mean serum glucose, fructosamine, and β-hydroxybutyrate concentrations. The trial also documented improvements in investigator-assessed physical condition and favorable owner evaluations of both feline and personal quality of life, establishing bexagliflozin as an effective once-daily oral treatment option.

While bexagliflozin's efficacy is notable, its safety profile requires careful consideration. The most frequently observed adverse events in the trial were gastrointestinal, including emesis and diarrhea, along with anorexia, lethargy, and dehydration. Critically, the study reported eight serious adverse events, three of which led to death or euthanasia. The most important risk identified was euglycemic diabetic ketoacidosis, which was diagnosed in three cats and presumed in a fourth. In parallel, other therapeutic avenues have been investigated, though not as first-line monotherapies. For instance, a 2025 study demonstrated that the probiotic Bifidobacterium longum CKD1 reduced fasting blood glucose by 18.0% in diabetic cats and significantly lowered insulin requirements in insulin-treated subjects. This suggests a potential role for gut microbiome modulation as an adjunctive therapy, representing an area of emerging research in the evolving feline diabetes landscape.