On 5 November 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product NexGard Combo, Spot-on solution, intended for Cats. The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
Esafoxolaner is the S-enantiomer of afoxolaner, an ectoparasiticide belonging to the isoxazoline group. It acts as an antagonist at ligand-gated chloride channels (GABA), thereby blocking pre-and postsynaptic transfer of chloride ions across cell membranes, resulting in uncontrolled activity of the central nervous system and death of ectoparasites. Eprinomectin is a member of the macrocyclic lactone class, and active against gastrointestinal and extraintestinal nematodes. It causes an increase in the permeability of cell membranes to chloride ions, resulting in paralysis and death of the nematodes. Praziquantel is a synthetic isoquinoline-pyrazine derivative with activity against tapeworms. It acts by damaging the parasite’s integument resulting in paralysis and death of the cestodes.
The benefit of NexGard Combo is its efficacy in the treatment of cats with (or at risk from) mixed infections with ectoparasites and nematodes and cestodes. The product is also effective as part of a treatment strategy for the control of flea allergy dermatitis.
NexGard Combo is generally well tolerated by cats at the recommended dose; adverse reactions include uncommon and transient cases of hypersalivation, diarrhoea, anorexia, lethargy and emesis shortly after administration, and skin reactions at the application site. The veterinary medicinal product can cause eye irritation, and users are therefore advised to avoid contact of the applicator content with their fingers.
The full indication is:
For cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.
Treatment of infestations by fleas (Ctenocephalides felis). One treatment provides immediate and
persistent flea killing activity for one month.
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis.
Treatment of infestations by ticks. One treatment provides immediate and persistent tick killing
activity against Ixodes scapularis for one month and against Ixodes ricinus for five weeks
Treatment of infestations by ear mites (Otodectes cynotis).
Treatment of infections with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus
multilocularis, Joyeuxiella pasqualei and Joyeuxiella fuhrmanni).
Treatment of infections with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara
cati, L4 larvae and adults of Ancylostoma tubaeforme and Ancylostoma ceylanicum, and adult
forms of Toxascaris leonina and Ancylostoma braziliense).
Prevention of heartworm disease (Dirofilaria immitis) for one month.
Treatment of infections with feline lungworms (L4 larvae and adults of Troglostrongylus brevior).
Treatment of infections with vesical worms (Capillaria plica).”
Detailed conditions for the use of this product are described in the summary of product characteristics which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for NexGard Combo and therefore recommends the granting of the marketing authorisation.
1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
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