On 10 November 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Neoleish, nasal spray, solution, for dogs. The applicant for this veterinary medicinal product is CZ VETERINARIA, S.A.
Neoleish is an immunological veterinary medicinal product consisting of plasmid DNA containing LACK gene from Leishmania infantum (ATCvet code QI07AX) as active substance. The vaccine is intended to stimulate the immune system and elicit a protective immune response against Leishmania infantum. The LACK protein is expressed in promastigotes and amastigotes forms of different Leishmania species.
The benefit of Neoleish is the reduction of the risk to develop an active infection and/or clinical disease after exposure to Leishmania infantum in non-infected dogs from 6 months of age. The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to Leishmania infantum in zones with high infection pressure over a two-year period. In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in bone marrow, spleen, and lymph nodes.
Onset of immunity: 58 days after the primary vaccination course.
Duration of immunity: 6 months after the primary vaccination course.
An additional benefit of the vaccination with Neoleish is that it does not interfere with serological diagnostic tools for leishmaniosis, as infected dogs can be distinguished from vaccinated animals and be identified in the population.
Neoleish is well tolerated at the recommended dose, and only a transient increase of the temperature (1.3 ºC) for 4 hours is observed after the administration of an overdose of ten standard doses, followed by a second standard dose.
The appropriate CVMP guideline on data requirements for veterinary medicinal products intended for minor use or minor species/limited markets has been applied in the assessment of the application.
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) 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 Neoleish and therefore recommends the granting of the marketing authorisation.
1 Applicants 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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