New therapeutic indications for NexGard®, NexGard SPECTRA® and Broadline® approved by EMA

Ingelheim, Germany, 27 September 2019 – Boehringer Ingelheim, a world leading animal health company, announces it has received additiona^l marketing authorizations from EMA (European Medicines Agency), broadening the preventative impact of its existing products in pet health. These authorizations mean maximizing the preventive impact of existing products thanks to cutting-edge scientific developments as well as making significant contributions to keep pets and humans healthier and safer.

NexGard^® and NexGard SPECTRA^® are already indicated to fight eight species of ticks that afflict dogs. The new claim concerns indication against Ixodes hexagonus tick, reported from most European countries² in the natural habitat of its hosts, like forests, caves or parks. Apart from rabbits, foxes and mustelids, it infests and feeds on dogs, cats and even humans. This tick species may transmit the agent of Lyme disease³.

Another authorization concerns the use of NexGard SPECTRA^® to help prevent thelaziosis (eyeworm occurrence in dog) which leads to conjunctivitis and keratitis. Corneal ulcers, perforation and blindness may occur in severe forms. For decades, the distribution of such eyeworms has been limited to Asia and the former Soviet Union; however, the parasite is now spreading in Europe⁴. In addition, human cases have also been reported⁵.

The last authorization is for Broadline^® in the treatment of intestinal infestations with Ancylostoma ceylanicum hookworm⁶ which affects cats and dogs. Despite the small size of this worm, its implications can be big in severe infestations, with chronic intestinal blood loss leading to anaemia. Infested cats and dogs contaminate the environment, which then becomes a source of infestation for humans. This zoonotic worm is the only hookworm that fully develops in humans, causing the same clinical signs as in companion animals. Therefore, the new therapeutic indication enlarges Broadline^® wide spectrum to further protect cat health while also contributing to human health.

“We are extremely pleased with the approval of these new indications by EMA. They are a testimony to our strong focus on prevention and improving health of animals,” shared Jean-Luc Michel, Head of Companion Animals Business Unit, Boehringer Ingelheim.

Boehringer Ingelheim Animal Health Business Unit

Boehringer Ingelheim is the second largest animal health business in the world, with net sales of almost 4 billion euros in 2018 and presence in more than 150 markets.

Across the globe, our 10,000 employees create the future of animal wellbeing through their daily work. We believe in prevention over treatment and therefore, we focus on developing innovative solutions in the field of vaccines, parasiticides and therapeutics. With a large portfolio of advanced, preventive healthcare products, tools and services, we support our customers in taking care of the health of their animals.

For more information visit: www.boehringer-ingelheim.com/animal-health/overview.

Boehringer Ingelheim

Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our latest product authorizations by EMA. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

¹https://ec.europa.eu/health/documents/community-register/html/reg_last.htm   

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Marotel, M.L.S. (2006) Tiques des carnivores domestiques en regions Rhone-Alpes, Auvergne, Limousin, Midi-Pyrenees, Aquitaine. Enquete de Juin a Decembre 2004. These Doct Vet, Ecole Nat Vet Toulouse.

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⁶https://www.aavp.org/wiki/nematodes/strongylida/ancylostomatoidea/ancylostoma-ceylanicum/