Authorities acknowledge reduction of Salmonella after vaccination with Enterisol® Ileitis

Ingelheim, Germany, January 7, 2021 – Boehringer Ingelheim, a global leader in animal health, announces that the Paul Ehrlich Institute (PEI), as the competent authority of the Reference Member State (Germany) under the Mutual Recognition procedure (MR), accepted new language on the label of Enterisol^® Ileitis. The national marketing authorization is granted pursuant to the Animal Health Act (TierGesG) and the Animal Vaccine Regulation. The PEI confirmed that Enterisol® Ileitis reduces prevalence of Salmonella infection and Salmonella seroprevalence at slaughter.

The request for a variation to the Enterisol^® Ileitis Summary of Product Characteristics to add new wording in the section ‘Immunological Properties’ was accepted by this competent authority and following completion of the MR procedure, identical authorizations will be granted in all EU Member States that have been included in the registration.

Ileitis caused by Lawsonia intracellularis is a costly disease affecting the digestive system of pigs in all pig rearing countries. Enterisol^® Ileitis is the only global oral live Lawsonia intracellularis vaccine to control Ileitis in swine. Salmonella infections in swine can lead to both clinical disease, production losses and food safety risks in pork.

“This additional label language for Enterisol^® Ileitis has been possible due to submission of both challenge studies and field observations in several countries. The studies showed that in pigs co-infected with both Lawsonia and Salmonella, vaccination with Enterisol® Ileitis reduced the prevalence of Salmonella infection and Salmonella seroprevalence at slaughter,” explains Dr Ricarda Deitmer, Enterics Technical Manager, Germany, Boehringer Ingelheim Animal Health.  

Furthermore, several authorities (PEI and rapporteurs in the countries) confirmed that the oral administration of this live vaccine is leading to a modulation of the intestinal microbiome. The positive effect on the microbiome results in more short chain fatty acids producing bacteria, which in turn reduces Salmonella infections as demonstrated in a recent publication¹.

The Paul Ehrlich Institute

The Paul-Ehrlich-Institut (PEI) is the Federal Institute for Vaccines and Biomedicines. As a federal regulatory authority active in the field of pharmaceuticals, its work is in the service of public health.

The PEI examines and evaluates the benefits and risks of human biomedical and immunological veterinary medicinal products as part of clinical development, marketing authorization and post-marketing follow-up.

Indispensable for the tasks of the PEI is its own experimental research. The PEI reports to the Federal Ministry of Health. The institute employs around 800 people at its location in Langen. www.pei.de/institut

Boehringer Ingelheim Animal Health

The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. Across the globe, our 10,000 employees are dedicated to delivering value through innovation, thus enhancing the well-being of both.

Respect for animals, humans and the environment is at the heart of what we do. We develop solutions and provide services to protect animals from disease and pain. We support our customers in taking care of the health of their animals and protect our communities against life- and society-threatening diseases.

Boehringer Ingelheim Animal Health is the second largest animal health business in the world, with net sales of 4 billion euros in 2019 and presence in more than 150 countries. For more information visit: www.boehringer-ingelheim.com/animal-health/overview.

Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found on www.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 global business. 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

¹Leite et al, 2018