The Committee adopted by consensus a positive opinion for a marketing authorisation application for Cepeloron (spironolactone), from CP-Pharma, a new product for the treatment of congestive heart failure caused by degenerative mitral valve disease, in combination with standard therapy (including diuretic support, where necessary) in dogs.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Cevac Salmune ETI K from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of chickens (breeders and layers) from 10 weeks of age to reduce faecal excretion of Salmonella Enteritidis, Salmonella Typhimurium and Salmonella Infantis.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Porcilis PCV M Hyo ID from Intervet International B.V., a new vaccine intended for the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, and faecal virus shedding caused by porcine circovirus type 2 (PCV2) infection and severity of lung lesions caused by Mycoplasma hyopneumoniae infection and to reduce the loss of daily weight gain during the finishing period in face of infections with PCV2 and/or Mycoplasma hyopneumoniae.
The Committee adopted by consensus a positive opinion for a variation requiring assessment (subject to a worksharing procedure) for Profender (praziquantel/emodepside) to implement the outcome of the MAH’s signal management process to add adverse reactions to the product information.
The Committee adopted by consensus positive opinions for variation requiring assessment concerning quality-related changes for:
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:
Senvelgo (velagliflozin) oral solution: known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus
Following a review of cases of diabetic ketoacidosis (DKA, a potentially fatal complication of diabetes mellitus) in cats given the medicine Senvelgo, the CVMP has agreed on a direct animal healthcare professional communication (DaHPC) with important information about the safe use of the medicine, including those situations that may require immediate intervention.
Senvelgo is used to reduce hyperglycaemia (high blood glucose levels) in cats with non-insulin-dependent diabetes mellitus. Before starting treatment with Senvelgo, cats must be screened for DKA and treatment should not be started if clinical signs indicative of DKA are present. Not all diabetic cats may be suitable for treatment with Senvelgo, especially those currently being treated with insulin, and careful patient selection is important. Diabetic cats pre-treated with insulin have a higher risk of developing DKA and ketonuria (high ketone levels in urine) when Senvelgo is started, compared to newly diagnosed cats.
Cases of DKA and deaths have been reported in cats given Senvelgo, including cases where unsuitable cats were switched from insulin to Senvelgo. Most DKA cases occurred within four days after starting treatment with Senvelgo. Based on pharmacovigilance adverse event reports, it is important to screen for the presence of ketone bodies every day during the first week of treatment, and every one to three days in the following week. In addition, blood testing for ketones should ideally be performed within this first 2-week period.
Veterinarians should inform cat owners of the risk of DKA, and seek to ensure that cat owners are able to adequately monitor their cats for potential development of this condition. Cat owners should immediately consult a veterinarian if they observe clinical signs of DKA such as weight loss, dehydration, lethargy (lack of energy), anorexia (loss of appetite), vomiting, cachexia (muscle wasting with significant weight loss) or if ketones are detected in the cat’s urine (e.g. using urine test strips).
If DKA or diabetic ketonuria are suspected or confirmed, treatment with Senvelgo must be stopped immediately. Appropriate investigation and immediate initiation of appropriate therapy (e.g. insulin therapy to stop the progression of ketoacidosis) is required.
The DaHPC for Senvelgo will be disseminated to animal healthcare professionals by the marketing authorisation holder, according to an agreed communication plan. The DaHPC has also been published on the Direct healthcare professional communications page on the EMA website.
Additional information about Senvelgo, including the product information for veterinarians and cat owners in all EU official languages, is available on the medicine’s webpage on the Veterinary Medicines Information website .
The Committee adopted four scientific advice reports further to requests for initial advice concerning three biological products and one pharmaceutical product. The respective target species were salmon (one product), dogs (two products), mice and rats (one product).
Efficacy
The Committee adopted a concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats (EMA/CVMP/EWP/259765/2024) for release for a 3-month period of public consultation. This concept paper addresses the need for a thorough revision of the guideline, in line with current scientific knowledge in the field and regulatory requirements.
The Committee adopted a concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/247519/2024) for release for a 3-month period of public consultation. This concept paper addresses the need for a comprehensive revision of the guideline, in line with current scientific knowledge in the field and regulatory requirements.
The Committee adopted a concept paper on the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/256158/2024) for release for a 3-month period of public consultation. This concept paper addresses the need for a thorough revision of the guideline, in line with current scientific knowledge in the field and regulatory requirements.
Environmental risk assessment
The Committee adopted a revised guideline on determining the fate of veterinary medicinal products in manure (EMA/CVMP/ERA/430327/2009-Rev.1*). This guideline has been developed to provide guidance on the execution and interpretation of studies on the transformation of veterinary medicinal products in manure. The revision consists of changes made in order to incorporate reference to new guidance and to correct and update the wording of the document, where appropriate.
The Committee adopted a revised reflection paper on poorly extractable and/or non-radiolabelled substances (EMA/CVMP/ERA/349254/2014-Rev.1*). This reflection paper has been developed to address issues which can arise when performing testing with poorly extractable and/or non-radiolabelled substances. The revision consists of changes made to correct and update the wording of the document, where appropriate.
Safety
The Committee adopted a concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/SWP/564774/2023) for release for a 3-month period of public consultation. The concept paper introduces the need to update references included in the guideline, to align more closely with the Guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/721059/2014), and to take account of experience gained through use of the guideline.
Quality
The Committee adopted a draft guideline on development and manufacture of synthetic oligonucleotides (EMA/CHMP/CVMP/QWP/262313/2024) for a 6-month period of public consultation. The purpose of this guideline is to set out the type of information required for the development, manufacture and control of synthetic oligonucleotides (existing or new chemical entities) used in a medicinal product, in the context of obtaining a marketing authorisation.
The Committee adopted a Q&A on co-processed excipients (CoPEs) used in solid oral dosage forms for a 3-month period of public consultation. The aim of this Q&A is to harmonise and clarify requirements for CoPEs using a risk-based approach; the Q&As are applicable to human and veterinary solid oral dosage forms. Retrospective application of the Q&As is not intended for marketed products, unless there are changes to the formulation (e.g. introducing a CoPE or changes to the applied CoPE).
MRL
The Committee adopted a Q&A on standard animal weights to be used for estimating worst-case consumer exposure scenarios to complement the guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling withing the scope of Regulation (EC) No 470/2009 (EMA/CVMP/516817/2009).
Pharmacovigilance
The Committee adopted the following standard list used for electronic reporting of suspected adverse reactions following the yearly review and update:
The Committee adopted the revised guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans (EMA/CVMP/PhVWP/288284/2007) and the non-current VeDDRA LLT terms and codes (EMA/CVMP/PhVWP/360871/2010).
The implementation of the standard lists in EudraVigilance Veterinary is provisionally scheduled for 1 October 2024.
The Committee adopted the scientific advice for the establishment of a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months (EMA/CVMP/159047/2023). This advice relates to the implementing act referred to in Article 115(5) of Regulation (EU) 2019/6. The purpose of this list is to help ensure the availability of treatments for Equidae.
More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in 'Related content'.