Merck’s canine dermatitis drug Numelvi gets positive EU opinion

Published 12/06/2025, 21:50
Merck’s canine dermatitis drug Numelvi gets positive EU opinion

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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.