Merck Animal Health Receives EU CVMP Positive Opinion for NUMELVI (atinvicitinib) Tablets for Dogs

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), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a 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.