MSD Animal Health Receives EU Approval of INNOVAX®-ILT-IBD

First EU-licensed poultry vaccine to prevent development of ILT, IBD and MD without the risk of reversion to virulence of ILT

Rahway, N.J., June 12, 2023 – MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today that the European Commission has approved INNOVAX®-ILT-IBD, a dual-construct HVT vaccine that provides long-term protection against infectious laryngotracheitis (ILT), infectious bursal disease (IBD) and Marek’s disease (MD). Following the centralized approval procedure, all European Union countries in which INNOVAX-ILT-IBD is licensed will update their national registrations.

INNOVAX-ILT-IBD is the first and only vaccine approved in the EU to provide combined protection against the development of ILT, IBD and MD in a single injection. The approval follows a positive opinion from the Committee for Veterinary Medicinal Products (CVMP) received in April 2023.

“For decades, MSD Animal Health has discovered and developed innovative, science-driven ways to preserve poultry well-being while maximizing our customers’ potential to contribute to global food production and safety,” said Fernando Vargas, Global Poultry Technical Director at MSD Animal Health. “Currently, there are no products available in the EU that prevent both, infectious laryngotracheitis, or ILT, and infectious bursal disease, without the risk of reversion to virulence. These are two of the most threatening diseases to poultry operations, making prevention by vaccination and biosecurity measures essential. With INNOVAX-ILT-IBD, poultry producers can have peace of mind that their birds have protection against three viruses in one.”

Building on MSD Animal Health’s legacy of protection offered by INNOVAX-ILT, INNOVAX-ILT-IBD features two ILT glycoprotein inserts instead of one. Furthermore, clinical trial data show that INNOVAX-ILT-IBD has an early onset and a long duration of immunity.1

“Infectious laryngotracheitis and infectious bursal disease are highly contagious respiratory diseases that can quickly infect entire poultry farms, causing stress and other debilitating symptoms that can have a long-term effect on health and productivity,” said Fernando Vargas, Global Poultry Technical Director at MSD Animal Health. “While we’ve seen tremendous preventive advancements in the field with monovalent vector vaccines, recent studies show that monovalent HVT vaccines can interfere with one another when combined – causing gaps in protection. We are thrilled to introduce INNOVAX-ILT-IBD, which combines the proven efficacy of our individual ILT and IBD vaccines into one vaccine, providing life-long protection for chickens while saving time and labor in the field.”

INNOVAX-ILT-IBD can be administered in the hatchery to layers and breeder flocks to increase early-life protection, and to broilers, both by subcutaneous injection (at day-old) or in ovo application (around 18 days of incubation). The product can be used in combination with other MSD Animal Health poultry products, including NOBILIS® RISMAVAC, NOBILIS® ND Clone 30, NOBILIS® ND C2, NOBILIS® IB Ma5 or NOBILIS® IB 4-91.

Detailed conditions for the use of INNOVAX-ILT-IBD in chickens described in its Summary of Product Characteristics (SPC) will be translated in all EU languages for publishing by individual regulatory authorities.

About MSD Animal Health

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of MSD. Through its commitment to The Science of Healthier Animals®, MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com and connect with us on LinkedIn and Twitter.

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This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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References

  1. INNOVAX-ILT-IBD Prescribing Information, Rahway, NJ: MSD Animal Health.