FDA Approves NUMELVI™ (atinvicitinib tablets) for Dogs from Merck Animal Health – The First and Only Second-Generation Janus Kinase (JAK) Inhibitor for the Control of Pruritus Associated with Allergic Dermatitis
RAHWAY, N.J.--( BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the U.S. Food and Drug Administration (FDA) approval of NUMELVI™ (atinvicitinib tablets) – the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs six months of age and older. The product is expected to be available at veterinary clinics and hospitals nationwide in spring 2026.
“Merck Animal Health is proud to introduce NUMELVI, our latest advancement geared at rapidly controlling pruritus associated with allergic dermatitis, a common condition that causes distress for so many pets and pet owners,” said Christine McKinney, DVM, DACVD and Senior Professional Services Veterinarian, Merck Animal Health.
“With more than 70 years of innovation and commitment to animal health, we are confident that NUMELVI will offer veterinary professionals a groundbreaking, first-of-its-kind solution aimed at improving the health and well-being of dogs – from as young as six months to mature dogs – and ultimately providing peace of mind for the people who care for them,” added McKinney. “NUMELVI also offers added convenience for veterinary clinics; most dogs, starting at weights as low as 4.4 pounds, require only one or half of a tablet, and there is no need to adjust vaccination schedules. Plus, NUMELVI comes in easy to dispense bottles and can be stored under standard conditions. Its active ingredient is intrinsically stable, eliminating the need for a protective film coat or specialized packaging and providing the longest shelf life among JAK inhibitor tablets in veterinary medicine.”
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“Merck Animal Health is continuously working to expand its portfolio to include innovative veterinary medicinal products that meet the needs of dogs and their owners,” said Tim Kowalski Distinguished Scientist, Discovery Research, Merck Animal Health. “NUMELVI, a second-generation JAK inhibitor, is the first of its kind to enter the market in veterinary medicine, giving it a unique profile compared with other JAK inhibitors. Second-generation JAK inhibitors are already considered the standard of care in human health, and NUMELVI brings that same advanced approach to veterinary medicine.”
For more information about the first and only second-generation JAK inhibitor for the treatment of allergic dermatitis in dogs from six months of age, visit numelvi.com.
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About Merck Animal Health
Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. 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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IMPORTANT SAFETY INFORMATION: NUMELVI (atinvicitinib tablets) is not for use in dogs less than 6 months of age or those with serious infections. NUMELVI may increase susceptibility to opportunistic infections, including demodicosis and interdigital furunculosis. Consider the risks and benefits of treatment prior to initiating NUMELVI in dogs with a history of recurrent demodicosis. NUMELVI is a JAK inhibitor. New neoplastic conditions (benign and malignant) have been reported in dogs treated with other JAK inhibitors. The effectiveness and safety of NUMELVI have not been evaluated in a field study beyond 28 days. The safe use of NUMELVI has not been evaluated in breeding, pregnant, or lactating dogs, nor in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. For complete safety information, refer to the product label.