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RAHWAY, N.J. - Merck Animal Health, a division of Merck & Co. (NYSE:MRK), which InvestingPro data shows maintains a "GREAT" financial health score of 3.24, announced Thursday that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has issued a positive opinion for NUMELVI (atinvicitinib) Tablets for Dogs, a treatment for canine allergic dermatitis.
If approved by the European Commission, NUMELVI will become the first and only second-generation Janus kinase (JAK) inhibitor for treating pruritus (itching) associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs. The European Commission is expected to make a final decision during the third quarter of 2025. This expansion aligns with Merck’s strong market position, reflected in its impressive 77% gross profit margin and $63.9 billion in revenue over the last twelve months.
The once-daily oral medication is designed to be at least 10-fold more selective for JAK1 compared to other JAK family members, which the company states minimizes interference with cytokines involved in immune functions. According to the press release, this selectivity results in a safety profile that allows use in dogs as young as six months of age without affecting immune response to vaccinations.
Itch affects more than 20 percent of dogs in general veterinary practice and is one of the most common reasons for veterinary visits. The condition can significantly impact quality of life for both dogs and their owners.
"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," said Holger Lehmann, vice president and global head of research and development for pharmaceuticals at Merck Animal Health, in the company’s statement.
Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is a division of Merck & Co., Inc. (NYSE:MRK).
In other recent news, Merck & Co Inc has initiated a Phase 3 clinical trial to evaluate its dengue vaccine candidate, V181. This large-scale study will enroll approximately 12,000 children aged 2 to 17 across several Asia-Pacific regions. The trial aims to assess the vaccine’s efficacy and safety against all four dengue virus serotypes. Meanwhile, Cantor Fitzgerald has maintained a Neutral rating on Merck, setting a price target of $85. The firm’s analyst, Carter Gould, discussed potential changes in the dosage regimen for Merck’s Gardasil vaccine, which could impact U.S. sales estimates. Additionally, Merck’s respiratory syncytial virus (RSV) vaccine, Enflonsia, recently received FDA approval. This approval introduces competition for Sobi’s Beyfortus, potentially affecting Sobi’s royalty revenue. Analysts have predicted a 10% decline in Beyfortus sales in the U.S. this year due to Enflonsia’s market entry.
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