Zoetis updates Librela label after post-approval data

Published 04/02/2025, 14:14
Zoetis updates Librela label after post-approval data

PARSIPPANY, N.J. - Zoetis Inc . (NYSE: NYSE:ZTS), a global leader in animal health with a market capitalization of $77.57 billion, has announced an immediate update to the U.S. label for its canine osteoarthritis pain control product, Librela (bedinvetmab injection). According to InvestingPro data, Zoetis maintains strong financial metrics with a 70% gross profit margin and healthy revenue growth of 9.3% over the last twelve months. The update follows a review of post-approval experiences since the product’s U.S. launch in October 2023. The company stated that it remains confident in the safety and efficacy of Librela and is committed to supporting veterinarians and pet owners in managing dogs with osteoarthritis.

Librela, a once-monthly injectable monoclonal antibody, was initially approved by the U.S. Food and Drug Administration in May 2023. The therapy targets Nerve Growth Factor (NGF) to alleviate pain associated with osteoarthritis in dogs. Since its introduction to the U.S. market, over one million dogs have been treated with Librela.

The label update is a response to real-world drug experience data reported to the FDA and collected through Zoetis’ pharmacovigilance monitoring. Label changes in the pharmaceutical industry are common, especially within the first few years following a product’s launch, to reflect post-market data.

Globally, Librela has been distributed in nearly 25 million doses, with no individual adverse event reported at a rate higher than "rare," as defined by the European Medicines Agency. This classification indicates less than 10 occurrences per 10,000 treated animals. The company’s strong market position is reflected in its robust financial health, earning a "GREAT" overall score on InvestingPro’s comprehensive assessment framework, with particularly strong scores in profitability and growth metrics.

Dr. Richard Goldstein, Global Chief Medical (TASE:PMCN) Officer and Head of Medical Affairs for Zoetis, emphasized the importance of informed decision-making for pet owners in collaboration with their veterinarians. He stated that nearly 25 million global doses stand testament to Librela’s positive impact on dogs with osteoarthritis pain.

In support of veterinary professionals and pet owners, Zoetis has made the updated U.S. Librela label and associated Client Information Sheet available on its website and will include them in future product distributions. The company also offers numerous resources, including data, research, and access to experts in the field of osteoarthritis. Over the past year, Zoetis has conducted more than 1,000 medical education webinars for veterinarians and provides local field veterinarians for ongoing support.

Librela has been approved for use in multiple countries, including Europe, Canada, Brazil, Australia, New Zealand, Japan, and other markets in South America and Asia.

This news is based on a press release statement from Zoetis Inc. The company’s solid financial foundation is evidenced by its comfortable liquidity position with a current ratio of 3.69, indicating strong ability to meet short-term obligations. For deeper insights into Zoetis’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro, which provides detailed analysis of the company’s performance metrics and future outlook.

In other recent news, Zoetis Inc., a leading animal health company, has reported robust growth in its third-quarter financial performance, with a 14% operational revenue increase reaching $2.4 billion, and a 15% rise in adjusted net income to $716 million. This growth was primarily driven by demand for its osteoarthritis pain treatments, Librela and Solensia, and the continued success of the Simparica franchise and dermatology portfolio. The company has consequently raised its revenue guidance for 2024 to between $9.2 billion and $9.3 billion, with adjusted net income expected to be between $2.67 billion and $2.695 billion.

In other organizational developments, Zoetis announced the appointment of Jamie Brannan as Chief Commercial Officer as part of a broader organizational restructuring aimed at enhancing the company’s commercial strategy and expanding its global market presence. This move signals a strategic shift to foster long-term growth and capitalize on new market opportunities.

Stifel analysts have maintained their Buy rating on Zoetis shares but adjusted the price target to $180 from the prior target of $210. This follows a detailed analysis of the company’s potential revenue streams and product performance, particularly focusing on the U.S. market for Librela. Despite adjusting its revenue estimates for Librela downwards for the years 2025 and 2026, Stifel’s analysis projects a 6.9% organic revenue growth worldwide for Zoetis in 2025, driven by the strong performance of other key products in the company’s portfolio.

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

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