Withdrawal of the marketing authorisation application
The applicant OTR3 submitted on 27 January 2017 an application for a marketing authorisation to the European Medicines Agency (The Agency) for EQUITEND, through the centralised procedure under Article 3(2)(a) of Regulation (EC) No 726/2004 (optional scope).
The eligibility to the centralised procedure was agreed upon by the CVMP on 14 July 2016 as EQUITEND contains a new active substance polycarboxymethyl glucose sulfate acetate (OTR4131) which was not authorised as a veterinary medicinal product in the Union on the date of entry into force of Regulation (EC) No 726/2004. The applicant applied for the following indication: Aid in healing flexor tendinopathy in sport horses.
The active substance of EQUITEND is polycarboxymethyl glucose sulfate acetate (OTR4131), a dextran derivative polymer, specifically designed to replace degraded heparan sulfates in injured muscle and tendonal structures. The pharmacological mechanism of action of polycarboxymethyl glucose sulfate acetate (OTR4131) is based on the binding and protection of growth factors and structural proteins in the extracellular matrix to restore the matrix scaffold and tissue architecture, and provide a micro-environment that is recognized by the cells of origin, aiding the natural process of tissue regeneration. The target species is horse.
EQUITEND contains 1 ml of 10 μg/ml polycarboxymethyl glucose sulfate acetate solution for injection and is presented in packs containing 1 vial.
The applicant is 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 12(3) of Directive 2001/82/EC – full application.
On 5 November 2018, OTR3 communicated the withdrawal of the marketing authorisation application at day 120 of the procedure. In its letter notifying the EMA of the withdrawal of the application, the applicant stated the reason for the withdrawal was based on insufficient funds to perform a new clinical field study as requested by the CVMP to support the claimed indication.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').