Horse Allo 20

allogeneic equine adipose-derived mesenchymal stem cells

Opinion

On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion*, recommending the refusal of the granting of a marketing authorisation for the veterinary medicinal product Horse Allo 20, a stem-cell based product presented as a suspension for injection.

Horse Allo 20 was proposed for the treatment of lameness associated to osteoarthritis in adult horses.

The applicant for this veterinary medicinal product is Centauri Biotech SL.

The active substance of Horse Allo 20 is allogeneic equine adipose-derived mesenchymal stem cells with potential immunomodulatory and anti-inflammatory properties that may be attributed to their paracrine activity and can possess tissue regenerative properties.

The grounds for the negative opinion relate to quality, safety and efficacy issues.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit to risk balance for Horse Allo 20 was not demonstrated to be favourable and therefore cannot recommend the granting of a marketing authorisation.


* 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.

Key facts

Name
Horse Allo 20
Agency product number
EMEA/V/C/004328
International non-proprietary name (INN) or common name
  • allogeneic equine adipose-derived mesenchymal stem cells
Species
Horses
Active substance
  • allogeneic equine adipose-derived mesenchymal stem cells
Date opinion adopted
21/06/2018
Company name
Centauri Biotech SL
Status
Negative
Application type
Initial authorisation

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