Sirolimus TriviumVet

Application withdrawn

The application for this medicine has been withdrawn

sirolimus

Overview

The applicant TriviumVet DAC submitted on 25 April 2023 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Sirolimus TriviumVet, through the centralised procedure under Article 42(2)(c) of Regulation (EU) 2019/6 (mandatory scope).

The eligibility to the centralised procedure was agreed upon by the CVMP on 10 November 2022 as Sirolimus TriviumVet contains an active substance which was not authorised as a veterinary medicinal product within the Union at the date of the submission of the application (Article 42(2)(c)).

At the time of submission, the applicant applied for the following indication:

‘Management of left ventricular hypertrophy associated with hypertrophic cardiomyopathy (HCM) in cats.’

The active substance of Sirolimus TriviumVet is sirolimus (also known as rapamycin), a macrolide compound, which inhibits mTOR complex 1 (mTORC1), a protein that is part of a signalling pathway regulating cell growth, autophagy, and cell death. According to the applicant, intermittent dosing with sirolimus specifically inhibits mTOR complex 1 (mTORC1), which results in a reduction in cardiac hypertrophy, an increase in mitophagy and autophagy and a reduction in oxidative stress. The target species is cat.

Sirolimus TriviumVet gastro-resistant tablets contain 0.4 mg, 1.2 mg, and 2.4 mg sirolimus and was presented in packs containing 12 tablets.

The applicant was registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

The dossier was submitted in line with the requirements for submissions under Article 8 of Regulation (EU) 2019/6 – full application.

On 18 March 2025, TriviumVet DAC withdrew the application during the assessment of the responses to the list of outstanding issues at day 187 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated the reason for the withdrawal: CVMP considers that the data provided does not allow the Committee to conclude on a positive benefit-risk balance.

Key facts

• Name of medicine:
  Sirolimus TriviumVet
• Active substance:
  sirolimus
• International non-proprietary name (INN) or common name:
  sirolimus
• Species:
  Cats
• EMA product number:
  EMEA/V/C/006230
• Marketing authorisation applicant:
  TriviumVet DAC
• Withdrawal of application:
  18/03/2025

All documents

Withdrawal assessment report for Sirolimus TriviumVet

Adopted Reference Number: EMA/108424/2025

Withdrawal letter : Sirolimus TriviumVet