Merck Animal Health receives EU CVMP positive opinion for NUMELVI

Merck (MRK) Animal, a division of Merck & Co., “announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products issued a positive opinion for NUMELVI 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. 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.”