Zoetis Inc. announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Portela® (relfovetmab), a monoclonal antibody therapy for alleviating pain associated with osteoarthritis in cats. If approved, Portela would become the first long-acting anti-nerve growth factor (NGF) monoclonal antibody therapy for felines.
Revolutionary Three-Month Treatment Duration
Portela is designed to provide three months of osteoarthritis pain relief with a single injection, targeting NGF, a key mediator of osteoarthritis pain. The CVMP recommended granting marketing authorization based on a positive benefit-risk balance of the safety and efficacy data submitted. In clinical trials, Portela demonstrated effectiveness in alleviating osteoarthritis pain and was well tolerated, including by cats with kidney disease at IRIS stage 1, 2, or 3.
"The CVMP's positive opinion for Portela represents a significant step forward in advancing feline pain management," said Rob Polzer, Ph.D., Executive Vice President and President, Research and Development at Zoetis. "The long-acting antibody properties of Portela and its unique binding site to NGF will soon offer veterinarians and cat owners in the European Union a new option to alleviate pain associated with osteoarthritis, thereby helping to improve the quality of life for affected cats."
Addressing Significant Diagnostic Gap
Osteoarthritis represents a substantial unmet medical need in feline healthcare. The chronic and progressive joint disease is characterized by inflammation and breakdown of joints, leading to pain and mobility issues. Though up to 40% of all cats have clinical signs of osteoarthritis, these signs are often overlooked by pet owners, resulting in only 18% of affected cats being diagnosed with osteoarthritis pain by veterinary professionals.
The impact of chronic pain extends beyond mobility, affecting sleep, relationships, and cognition in cats. Portela's long-acting formulation offers particular benefits for cats that are difficult to medicate regularly, providing a convenient therapeutic option for both veterinarians and pet owners.
Expanding Zoetis' Pain Management Portfolio
If approved, Portela will expand Zoetis' osteoarthritis pain franchise alongside Solensia® (frunevetmab), an anti-NGF monoclonal antibody indicated for monthly alleviation of osteoarthritis pain in cats. Solensia, approved in more than 40 countries, has demonstrated pain relief and quality of life enhancement in clinical trials and over four years of real-world veterinary use.
"If approved, Portela will be a new, science-driven solution designed to support long-term comfort and mobility for cats—with the added benefit that pet owners only need to bring their cats in for an injection once every three months," said Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs at Zoetis. "Four years ago in the EU, we introduced the first monoclonal antibody therapy to control pain associated with OA in cats, and we look forward to providing veterinarians with another innovative tool to help them improve the quality of life for the animals in their care."
Regulatory Timeline and Commercial Launch
Based on the CVMP's positive opinion, the European Commission is expected to issue a decision during the fourth quarter of 2025. Zoetis anticipates making Portela commercially available in the European Union in 2026, pending final regulatory approval.