Zoetis Receives European Commission Marketing Authorization for Solensia® (frunevetmab), a New Therapy for Feline Osteoarthritis Pain

Rhea-AI Summary

Zoetis (NYSE:ZTS) has received marketing authorization from the European Commission for Solensia (frunevetmab), a groundbreaking treatment for feline osteoarthritis (OA). Affecting approximately 40% of cats, OA can severely impact their quality of life. Solensia is a monoclonal antibody that targets Nerve Growth Factor (NGF) to alleviate OA pain and is administered monthly by veterinarians. Clinical studies reveal that 76% of cat owners reported sustained improvements in their pets' pain symptoms, enhancing overall activity and sociability.

Positive

• Marketing authorization granted for Solensia, a new feline OA treatment.
• 76% of cat owners observed sustained improvement in their pets' pain symptoms.
• Solensia targets NGF, offering a novel approach to pain relief.
• Monthly administration simplifies treatment for cat owners and veterinarians.

Negative

• None.

Zoetis Inc. (NYSE:ZTS) today announced that the European Commission has granted the marketing authorization for Solensia^® (frunevetmab), a new feline osteoarthritis treatment to alleviate pain. Osteoarthritis in cats is a very prevalent condition¹, existing in 40% of cats, and may generate pain and limit a cat’s comfort and quality of life if not treated.

Solensia works differently from current treatment options by targeting Nerve Growth Factor (NGF), a key player in osteoarthritis (OA) pain.^1,2 It functions like naturally occurring antibodies, with minimal involvement of the liver or kidneys in their metabolism and elimination process, and minimal gastrointestinal impact.³ It is delivered by the veterinarian as a monthly injection (under the skin).

“At Zoetis, our monoclonal antibody research continues to advance the care of animals, and our platform allows us to explore new therapeutic areas for the management of diseases with high prevalence and high unmet needs,” said Catherine Knupp, DVM, MS, Executive Vice President and President, Research and Development at Zoetis. “OA pain in cats remains vastly undertreated, and Solensia is a prime example of our commitment to meaningful innovation in feline medicines. This monthly treatment is an effective new treatment option for veterinarians and cat owners, and we are very pleased to be granted the first approval of a monoclonal antibody therapy for alleviation of pain in cats.”

Improved quality of life for cats and their owners

By alleviating pain, Solensia helps generally improve physical activity level, sociability and quality of life of cats with OA. This new product’s benefits are effective pain relief, combined with a positive safety profile in a monthly injectable treatment for OA pain in cats. In a clinical study over three months, pet owners observed signs of pain, including physical activity level, sociability and quality of life. A total of 76% of cat owners reported sustained improvement in signs of pain when their cats were treated with Solensia.

Margaret E. Gruen⁴, DVM, MVPH, PhD, DACVB, Assistant Professor of Behavioral Medicine at North Carolina State University, said: “My clinical research, and personal experience, has shown that OA pain can affect cats in a variety of ways. It impairs their ability to perform their activities of daily living and negatively impacts their quality of life. OA pain can also affect sleep, cognitive function, affect (emotion) and social relationships.”

“NGF is one of the key factors mediating pain, inducing the release of both pro-inflammatory mediators and more NGF contributing to a cycle of pain and inflammation. Anti-NGF therapy could be the most exciting therapeutic advancement in more than 20 years in veterinary medicine to control OA pain, and I welcome this innovative tool for clinicians working to alleviate OA pain. The monthly administration makes it especially useful for cats, with the potential to bring pain relief to millions of cats who suffer from OA,” she said.

Veterinarians believe that Solensia would help more cats with OA pain be treated and for longer⁵.

Mike McFarland, DVM, Executive Vice President and Chief Medical Officer at Zoetis said: “In my experience, I have learned that cats can hide their pain well. Cat owners used to come in when their cats were showing signs of discomfort like sleeping more, irritability or lack of activity, but they thought these were just ‘normal’ aging behaviours. Thanks to Solensia, veterinarians will now have a breakthrough solution available for the management of pain associated with osteoarthritis in cats and will ultimately offer new alternatives to cat owners to improve the quality of life of their pets.”

Rob Kelly, Executive Vice President and President, International Operations at Zoetis concludes, “Our focus on feline medicines is not new. It includes a large portfolio of solutions to predict, prevent, detect and treat diseases with rapid-test diagnostics, vaccines and other preventative solutions like Stronghold Plus^® against several parasites, Cerenia^® for alleviation of vomiting and Synulox^® for the treatment of a wide range of bacterial infections in cats. We are very excited to now add Solensia to our portfolio of feline products, as a unique new solution for cat owners and veterinarians in the management of pain associated with osteoarthritis.”

The active substance of Solensia is frunevetmab, a monoclonal antibody (mAb) distinct to that used in Librela (bedinvetmab), its canine counterpart. Each was designed specifically for its target species.

About Solensia^® (frunevetmab)

Frunevetmab is a monoclonal antibody designed specifically for cats. It neutralizes Nerve Growth Factor (NGF), a key player involved in osteoarthritis in cats, and in doing so reduces pain. During the pivotal clinical trial, Solensia^® demonstrated a positive profile, and a total of 76% of cat owners reported sustained improvement in signs of pain when their cats were treated.

About Zoetis

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses in advancing care for animals. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines, diagnostics, technologies and services, including biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2020, the company generated annual revenue of $6.7 billion with approximately 11,300 employees. For more information, visit www.zoetis.com.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects and expectations regarding products. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

1. Enomoto M, Mantyh PW, Murrell J, et al. Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats. Vet Rec. 2019;184(1):23
2. Schmelz, M., Mantyh, P., Malfait, A.M., Farrar, J., Yaksh, T., Tive, L. and Viktrup, L., 2019. Nerve growth factor antibody for the treatment of osteoarthritis pain and chronic low-back pain: mechanism of action in the context of efficacy and safety. Pain, 160(10), p.2210.
3. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(8):493-507
4. Dr. Gruen has a consulting relationship with Zoetis.
5. Zoetis Veterinarian Market Research; Project November KG Market Sense 2018

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FAQ

What is Solensia and how does it work for ZTS?

Solensia (frunevetmab) is a monoclonal antibody treatment for feline osteoarthritis that targets Nerve Growth Factor to alleviate pain.

What percentage of cat owners reported improvements with Solensia?

In clinical studies, 76% of cat owners reported sustained improvements in their cats' pain symptoms after using Solensia.

When was Solensia authorized by the European Commission?

Solensia received marketing authorization from the European Commission on February 22, 2021.

What condition does Solensia treat in cats?

Solensia is designed to treat osteoarthritis, a prevalent condition affecting around 40% of cats.

What is the significance of Solensia for Zoetis (ZTS)?

The approval of Solensia represents a significant advancement in veterinary medicine, offering a new effective treatment option for OA pain in cats.