Merck Animal Health Receives Positive Opinion from EU CVMP for Numelvi Tablets for Dogs

Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., has announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has issued a positive opinion for Numelvi (atinvicitinib) tablets for dogs. This marks an important step toward the availability of Numelvi in the European Union.

Once fully approved by the European Commission, Numelvi will be the only second-generation Janus kinase (JAK) inhibitor specifically indicated for the treatment of pruritus (itching) associated with allergic and atopic dermatitis in dogs. The medication will be the first to target the JAK1-dependent cytokines responsible for itch and inflammation, offering a promising treatment option for a common and distressing condition in pets.

Numelvi is a once-daily, first-line treatment that is at least 10 times more selective for JAK1 than other JAK family members, such as JAK2, JAK3, and TYK2. This high selectivity reduces interference with cytokines involved in essential immune functions and haematopoiesis, ensuring a compelling safety profile. It has been proven to be effective in both adult dogs and puppies and will be the only JAK inhibitor that can be used in dogs as young as six months old. Furthermore, Numelvi’s treatment regimen does not impact the immune response to vaccination.

“We are pleased to be one step closer to making Numelvi available to veterinarians and pet owners across Europe,” said Rick DeLuca, executive vice president and president of Merck Animal Health. “This novel, highly selective JAK inhibitor is designed to help manage a condition that causes significant distress for both pets and their owners.”

Pruritus, or itching, affects more than 20% of dogs in general veterinary practice, making it one of the leading causes of veterinary visits. The condition is especially challenging for veterinarians to manage as it often requires prolonged treatment and regular follow-ups. As allergic dermatitis progresses, it impacts the quality of life for dogs, leading to emotional distress, sleep disruptions, and increased veterinary expenses.

“Numelvi offers a unique and effective solution to help control pruritus associated with allergic dermatitis in dogs,” added Holger Lehmann, DVM, PhD, vice president and global head of research and development for Merck Animal Health. “With a once-daily dosing regimen and a distinct safety profile, it also does not interfere with the response to core vaccinations, which is a significant advantage for veterinary care.”