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Zoetis Gains CVMP Backing for Lenivia, Eyes EU Approval in Dog OA Pain
ZACKS· 2025-10-13 18:11
Core Insights - Zoetis (ZTS) received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) for its investigational monoclonal antibody therapy, Lenivia, aimed at relieving osteoarthritis pain in dogs [1][5][6] - The final decision from the European regulatory body is expected in Q4 2025, with a potential commercial launch in 2026 [2][9] - Lenivia is designed to provide pain relief for up to three months with a single injection, targeting nerve growth factor (NGF) [3][8] Company Developments - The approval of Lenivia would enhance Zoetis' leadership in the animal health sector and expand its innovative portfolio in companion animal therapeutics [6] - Lenivia will complement the existing product Librela, providing veterinarians and pet owners with both monthly and quarterly treatment options for managing osteoarthritis pain in dogs [5][8] - The company has also received a positive opinion for another monoclonal antibody therapy, Portela, for managing osteoarthritis pain in cats, which is expected to launch in 2026 if approved [9][11] Market Context - Osteoarthritis is a common condition affecting nearly 40% of dogs, leading to significant pain and reduced mobility [7] - The introduction of Lenivia and Portela could deepen Zoetis' penetration into the growing canine and feline osteoarthritis market, improving treatment adherence due to less frequent dosing schedules [11]
Zoetis Gains CVMP Backing for Portela, Eyes EU Approval in Cat OA Pain
ZACKS· 2025-09-15 14:56
Core Insights - Zoetis has received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products for its monoclonal antibody therapy, Portela, aimed at alleviating osteoarthritis pain in cats [1][5] - The company anticipates a final decision from the European regulatory body in Q4 2025, with potential commercialization in 2026 [2] Product Development - Portela is designed to provide up to three months of pain relief with a single injection, addressing a significant unmet need in feline care where treatment options for chronic pain are limited [3][5] - The therapy has shown favorable safety and efficacy data, being well-tolerated even in cats with early-stage kidney disease [3] Market Positioning - The approval of Portela would mark a significant advancement in veterinary medicine, as it would be the first long-acting anti-NGF monoclonal antibody therapy for cats [3][9] - Portela is expected to complement Zoetis' existing anti-NGF therapy, Solensia, providing veterinarians and pet owners with both monthly and quarterly treatment options for osteoarthritis pain [9][10] Industry Context - Osteoarthritis affects up to 40% of cats, with only 18% formally diagnosed, highlighting the importance of early identification and treatment [8] - The introduction of Portela aligns with Zoetis' strategy of disruptive innovation in companion animal health, potentially deepening its market penetration in the growing feline osteoarthritis segment [10]