EMA recommended 20 new medicines for animals in 2014 - three of which are for minor species and rare diseases
In 2014, 20 new veterinary medicines were recommended for marketing authorisation by the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP). Amongst them, three medicines are intended for minor species or for rare diseases in major species, such as cattle or sheep.
These include the first vaccine against Schmallenberg virus in cattle and sheep to be recommended for authorisation at a European level. The virus, which has recently been discovered and has rapidly spread to several EU countries, can cause a drop in milk production in adult animals and attacks the brain and spinal cord of developing fetuses, damaging these organs and deforming legs, spine and head.
In 2014, the CVMP received the highest number of requests in a year (29) for the classification of veterinary medicines intended for minor use minor species (MUMS)/limited market. Since its introduction in September 2009, the MUMS/limited market policy has successfully stimulated the development of new veterinary medicines for minor species and for rare diseases in major species, with almost 100 products classified so far.
Among the 20 new veterinary medicines recommended for marketing authorisation in 2014, 11 are for companion animals, including a range of vaccines for dogs, and nine are for food-producing animals, including poultry, pigs, cattle and sheep.
The past year saw the first recommendation of a marker vaccine for the immunisation of pigs against classical swine fever virus. Classical swine fever is a highly contagious disease which can lead to death within two weeks. The disease is usually controlled within the European Union (EU) by 'stamping out', which involves the slaughter of all infected pigs and pigs that have been in contact with them. Unlike traditional vaccines, the new vaccine allows the identification of naturally infected animals, whether or not they have also been vaccinated. This makes it a useful tool in eradication campaigns as it opens up the possibility for control of the disease through vaccination rather than slaughter in circumstances where this is appropriate.
Four applications for the establishment of maximum residue limits (MRLs) for new substances were received in 2014. In the EU, an MRL determines how much of a medicine-derived residue can remain in food produced from a treated animal and is used to define the time that must elapse between the last treatment of an animal with a medicine and the collection of food stuffs from that animal. Although lower than the number of applications received in 2013 (when six applications were received), the number of applications received indicate the continued interest of the animal health industry in developing new medicines for food-producing animals.