FOI Request for evidence of Librela testing
Published 19 August 2025
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Request ATI1063
You claimed Librela was tested thoroughly before it went into production.
And that all the required tests were done.
Please send me this evidence
As I have a report that contradicts your claim
Our reply
Librela was authorised in the UK as part of a centralised procedure (Marketing authorisations for veterinary medicines - GOV.UK) involving joint assessment by the UK (part of the EU at the time) and all other EU member states. The information provided by the applicant (in this case Zoetis) fulfilled the criteria as laid out in the legislation at that time (submissions under Article 12(3) of Directive 2001/82/EC – full application) and this Directive’s technical annex, which detailed the studies that should be performed for a full application. Details of the studies performed with Librela are available in the public assessment report (Librela 10 mg - Solution for injection UPD, see downloadable pdf at the bottom of the web page). Based on the data presented, the overall benefit-risk was considered positive, and a marketing authorisation was granted.
Regarding monitoring for joint disease, radiographs were taken during the pivotal target animal safety study (page 14 in the public assessment report) in which doses up to 10x the recommended dose were administered for seven consecutive monthly injections. Radiographs of the femorotibial, hip, elbow, and scapulohumeral joints were taken during the acclimatisation period (before Librela was given) and after the last dose of Librela and Faxitron radiographs of the same joints were taken at post-mortem. Additionally, post-mortem physical examination of the same joints was performed.