Animal health pharmaceutical company Zoetis announced that the US Food and Drug Administration (FDA) has approved Librela for the control of pain associated with osteoarthritis (OA) in dogs.
The landmark treatment is the first monoclonal antibody approved in the US to control OA pain in dogs. According to Zoetis, the once monthly injection works differently from other pain medications as its unique mode of action targets Nerve Growth Factor (NGF), a key component of OA pain.
In 2020, Librela was granted marketing authorisation by the European Medicines Agency (EMA) and the product was launched in 2021 and has been used by veterinarians in Europe as a treatment option for OA pain in dogs with over 4.6 million doses distributed as of November 2022.
According to the pharmaceutical company, European veterinarians who have used Librela also rated the treatment very highly on top product attributes for OA pain medications, including: reduces OA pain, improves mobility, and improves quality-of-life.
“Zoetis has a 25-year legacy in pain management and has revolutionised how the veterinary industry approaches this critical area of pet care,” said Laura Olsen, Senior Vice President, US Petcare, at Zoetis. “The FDA approval of Librela represents a significant step forward in our ability to provide comfort to dogs living with the chronic pain associated with OA, ultimately strengthening the unbreakable bond people share with their pets.”
Many dogs suffer from osteoarthritis, a painful and progressive disease which causes inflammation in the joints and deterioration of the cartilage.
Zoetis cited data which showed 40% of dogs have signs of OA and with an estimated 86 million dogs living in the UUS households, a high percentage of dogs are likely experiencing OA pain. The disease not only impact older dogs, it also affects dogs of all ages, sizes, and breeds. It can even affect dogs as young as 1 year old.
Osteoarthritis can negatively impact a dog’s life including their physical and emotional wellbeing.
According to the American Kennel Club, signs for osteoarthritis in dogs include:
- Stiffness, lameness, limping, or difficulty getting up
- Lethargy
- Reluctance to run, jump, or play
- Weight gain
- Irritability or changes in behavior
- Pain when petted or touched
- Difficulty posturing to urinate or defecate, or having accidents in the house
- Loss of muscle mass over the limbs and spine
In two field studies, dogs administered Librela as a monthly injection demonstrated a reduction in OA pain compared to dogs that received the placebo and by reducing pain, Librela was shown to help their mobility and overall quality of life.
“While effectiveness may not be seen until after the second dose of Librela, some dogs may experience a reduction in pain as early as seven days after the first dose,” Zoetis stated. “Additionally, in a continuation study, dogs treated with bedinvetmab (Librela) experienced lasting OA pain relief over the course of the study with monthly injections.
“Pain is often overlooked in dogs for two primary reasons: the signs of OA pain are misinterpreted as normal ageing and OA pain is not considered in younger dogs,” said Duncan Lascelles, Professor of Translational Research in Pain and Surgery at North Carolina State University and recent past Chair of the WSAVA Global Pain Council. “As our understanding of canine pain expands, Librela provides a unique monthly treatment to control OA pain in dogs by targeting NGF, helping to improve their comfort, mobility and overall well-being.”
The most common adverse events reported in dogs treated with Librela included urinary tract infections, bacterial skin infections, dermatitis and increased blood urea nitrogen. Librela functions like naturally produced antibodies and is metabolised and eliminated via normal protein degradation pathways with minimal involvement of the liver or kidneys.
Zoetis stated, “Current treatment choices have limitations, including lack of effectiveness, difficulty in administration and safety concerns, which contribute to the overall low treatment rate for OA pain. With once-monthly injections administered by a veterinary professional, Librela may also reduce pet owner stress about missing a daily treatment dose and help maintain the human-animal bond.”
Zoetis told the American Animal Hospital Association that the treatment is expected to become available to US-based veterinarians in late 2023, and that’s not the only welcome news.
Sharon L. Campbell, medical affairs lead, canine chronic pain, at Zoetis, said, “Dogs in any stage of OA can be administered Librela: This means dogs can begin to receive treatment at the very first signs of OA pain.”
“In a recent study evaluating Librela use in Europe, veterinarians are using Librela 51% of the time in severe disease, 36% in moderate, and 13% in mild disease,” she continued.
Campbell said response to the treatment may vary but in the EU clinical study, dogs were treated for as long as nine months and maintained a response to therapy during that time. Those dogs ranged in severity of disease based on three components (general musculoskeletal condition, lameness/weight bearing, and pain on palpation/manipulation of the joint), but each dog had to have a severity score of moderate in at least one of those components to participate in the study.
“A missed dose is not a disaster,” Campbell added. If a dog missed one or more doses of Librela, it is likely that that dog will experience a relapse in OA pain. However, restarting the Librela should result in as good or nearly as good of a response as before.”
The treatment has also been approved for use in Canada, Brazil, Australia, New Zealand, Japan and other markets across South America and Asia.
Librela is expected to be available to veterinarians in the US in late 2023.