o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/783550/2013

EMEA/V/C/002729

EPAR summary for the public

NexGard

Afoxolaner

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal's medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is NexGard?

NexGard is a veterinary medicine that contains the active substance afoxolaner. It is available as chewable tablets in four different strengths for use in dogs of different weights.

What is NexGard used for?

NexGard is used to treat flea and tick infestations in dogs. It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites). NexGard is given as a tablet of the appropriate strength for the dog's bodyweight. After being given, its actions last for 5 weeks against fleas and one month against ticks. Treatment should be repeated at monthly intervals during the flea or tick seasons. NexGard kills fleas within 8 hours and ticks within 48 hours.

How does NexGard work?

The active substance in NexGard, afoxolaner, acts as an 'ectoparasiticide'. This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks. In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.

Afoxolaner kills fleas and ticks that have ingested the dog's blood by acting on their nervous system. It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter). This results in uncontrolled activity of the nervous system and the paralysis and death of the fleas and ticks. Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.

How has NexGard been studied?

The effectiveness of NexGard against fleas and ticks was investigated in both laboratory and field studies. One main field study in the EU involved 146 dogs with flea and/or tick infestations that were given a single treatment with NexGard or a spot-on medicine containing pyriprole that controls fleas and ticks. The measure of effectiveness was reduction in the number of fleas and ticks at day 7, 14, 21 and 30 after treatment.

What benefit has NexGard shown during the studies?

The EU field study showed that NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment. NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as pyriprole.

What is the risk associated with NexGard?

Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product. The blister should be returned into the carton.

People handling the medicine should wash their hands after handling the product.

Why has NexGard been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of NexGard exceed the risks for the approved indications and recommended that NexGard be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about NexGard:

The European Commission granted a marketing authorisation valid throughout the European Union, for NexGard on 11 February 2014. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in December 2013.

NexGard

EMA/783550/2013