Merck Animal Health Receives EU CVMP Positive Opinion for NUMELVI™ (atinvicitinib) Tablets for Dogs
NUMELVI, a once-daily, first-line treatment, will be the only second-generation Janus kinase (JAK) inhibitor indicated for the treatment of pruritus associated with allergic dermatitis including atopic dermatitis and treatment of clinical manifestations of atopic dermatitis in dogs, upon full approval by the European Commission. NUMELVI inhibits the function of JAK1-dependent cytokines involved in itch and inflammation in allergic and atopic dermatitis and is at least 10-fold more selective for JAK1 compared to the other JAK family members (JAK2, JAK3 and TYK2). JAK1 selectivity minimizes interference with cytokines involved in hematopoiesis and immune functions dependent on the other JAKs, resulting in a compelling safety profile with proven efficacy in dogs and puppies. Once approved, it will be the only JAK inhibitor that can be used in dogs as young as six months of age. With a once-daily treatment regimen, NUMELVI is clinically effective after the first dose. Treatment with NUMELVI had no impact on immune response to vaccination.
'Merck Animal Health has been committed to bringing innovation to our customers aimed at rapidly controlling and treating a common condition that causes distress for so many pets and pet owners,' said Rick DeLuca, executive vice president and president, Merck Animal Health. 'With today's positive opinion for NUMELVI, we are one step closer to making this novel, highly selective JAK inhibitor available.'
Itch is seen in more than 20 percent of dogs in general veterinary practice and is one of the most frequent reasons for veterinary visits. As allergic dermatitis progresses, quality of life in dogs declines and the relationship between a pet and its owner can be weakened due to emotional distress, interruptions in sleep and routines, increased expenses, and time lost to provide treatment and veterinary follow-up to manage an itchy dog. Veterinarians also face challenges in managing dogs with allergic dermatitis, as diagnosis and treatment takes time and requires regular progress checks.
'Merck Animal Health continues to deliver cutting-edge innovation and science with first- and best-in-class veterinary medicinal products that address important unmet needs,' said Holger Lehmann, DVM, PhD, vice present and global head, research and development for pharmaceuticals, Merck Animal Health. 'NUMELVI not only offers a once-daily dosing regimen but also features a distinctive safety profile that permits its use in dogs as young as six months. Additionally, a vaccine response study has shown that NUMELVI does not affect the immune response to core vaccinations.'
Based on the CVMP's recommendation, the European Commission is expected to issue a decision for marketing authorization in the European Union (EU) during the third quarter of 2025.
About Merck Animal Health
At Merck, known as MSD outside of 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. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals ®, Merck Animal Health offers veterinarians, farmers, producers, 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. Merck 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. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
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.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
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