Coliprotec F4/F18: Withdrawal of the application to change the marketing authorisation
The applicant submitted to the European Medicines Agency (the Agency) on 22 August 2018 an application for a type II variation for Coliprotec F4/F18. Coliprotec F4/F18 is a lyophilised vaccine for oral suspension for pigs and is intended for the active immunisation of piglets from 18 days of age against enterotoxigenic F4-positive and F18-positive Escherichia coli to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) and reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
The proposed type II variation was to add a new therapeutic indication to Coliprotec F4/F18 for the improvement of daily weight gain in pigs at risk of E. coli-related disease by reviewing existing laboratory data and the provision of new field studies; thus, the application initially proposed the following therapeutic indication:
“To improve daily weight gain in pigs at risk of E. coli related disease“.
The CVMP’s revised position paper on indications for veterinary medicines, EMEA/CVMP/042/97-Rev.1-Final, provides guidance on acceptable indications for immunological veterinary medicinal products (IVMPs) and refers to “active immunisation or passive immunisation of target species”, which is further elaborated to refer to “reduction of negative effects of the disease/disease complex on the performance of the target animal”. The performance claim proposed by the applicant: “to improve daily weight gain in pigs” as an additional indication for the immunological veterinary medicinal product Coliprotec F4/F18 was therefore not considered acceptable.
During the procedure the applicant revised the proposed claim to: “to reduce weight loss associated with E. coli F4 and/or F18 related diseases”. Whilst the revised claim to reduce weight loss would be in line with CVMP’s revised position paper on indications for veterinary vaccines (EMEA/CVMP/042/97-Rev.1-Final) and could therefore be acceptable in principle, it was considered that sufficient data had not been provided to support the claim.
The applicant requested an oral explanation to defend their position, which was held on the 21 May 2019. The applicant proposed at that time to amend the claim to: “under field conditions, reduction in weight loss associated with E. coli F4 and/or F18 related diseases have been demonstrated during the pre-fattening (nursery) period for a time period of 6-7 weeks”. However, the CVMP considered that the field data provided in support of a claim for a reduction in weight loss, which only covered a short period of the life of the pig, is not adequate as reduction in weight loss was not confirmed to be associated with the disease of interest.
In addition, if there was any reduction in weight loss, it should be shown to be sustained and related to the overall performance at the time of slaughter, in order to be a meaningful claim.
On 27 May 2019, a letter of withdrawal was received from the applicant.
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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').