Zoetis Launches Cytopoint® (lokivetmab) in the European Union

 

  • The first monoclonal antibody for veterinary use now available in the European Union
  • A single injection of Cytopoint treats the clinical manifestations of atopic dermatitis in dogs, including itch and inflammation, for up to one month
  • Targets and neutralizes canine interleukin-31 (cIL-31), a key cytokine involved in stimulating itch in dogs with atopic dermatitis
  • Another option to improve quality of life in atopic dogs and provide peace of mind for owners

 

LAUSANNE, SWITZERLAND – September 6th, 2017 –  Zoetis today announced the launch of Cytopoint (lokivetmab), the first monoclonal antibody (mAb) therapy available in the European Union for veterinary use. Cytopoint is indicated to treat the clinical manifestations, including itch and inflammation, associated with atopic dermatitis in dogs of any age weighing three kilograms or more. Cytopoint targets and neutralizes cytokine interleukin-31 in dogs (cIL-31), a key protein involved in triggering itch in dogs. Administered by injection once monthly, Cytopoint provides fast, long-lasting relief of itch – the hallmark sign of the allergic skin condition atopic dermatitis in dogs – and the inflammation and lesions it causes. Cytopoint helps improve the long-term health and quality of life for dogs suffering from atopic dermatitis and eases the related frustration and concern of their owners.

“My personal experience with Cytopoint showed impressive speed of efficacy, significantly reducing itch in dogs from 24 hours onwards,” said Dr. Annette van der Lee, a specialist in veterinary dermatology in Utrecht, the Netherlands, who participated in field studies conducted in Europe. “Atopic dermatitis is a very common disease in dogs, and the owners I meet are desperate to find a rapid, reliable and safe solution for their suffering dogs. With its once-monthly injection, I believe that Cytopoint has the potential to meet pet owners’ needs for its convenience. European veterinary dermatologists and veterinarians will now have access to a new therapeutic class via this first monoclonal antibody treatment for veterinary use. It is a very exciting innovation which brings a notable improvement to the health and quality of life of the dogs, and happiness to their families.”

“Atopic dermatitis is a very common disease in dogs with significant impact on the animals’ quality of life, often generating frustration for the owners,” said Dr. Chiara Noli, DVM and specialist in veterinary parasitology and dermatology in Milan, Italy. “Cytopoint offers a safe and sustainable solution for dogs and their owners.”

 

About Cytopoint

Cytopoint is a ready-to-use, sterile solution for injection containing the mAb lokivetmab. It is specifically designed to target and neutralize cIL-31, a key cytokine (protein important in cell-to-cell communication) involved in triggering itching associated with canine atopic dermatitis. It works by mimicking the activity of natural antibodies to selectively bind and neutralize IL-31, thus interrupting the itch cycle in atopic dogs.

Cytopoint begins working within eight hours and a single injection at label dose can deliver up to one month of relief from the clinical signs of canine atopic dermatitis, allowing damaged skin the chance to heal. In clinical studies submitted to European Medicines Agency, treatment with Cytopoint at a minimum dose of 1 mg/kg resulted in a clear benefit in the reduction of pruritus (itching) and showed a beneficial effect on the reduction of disease severity as evaluated by scoring the skin lesions.

It is safe for dogs of any age, even those with concomitant diseases, and can be used with many common medications, including vaccines. Moreover, because of the precision and specificity with which it acts to target and neutralize cIL-31, it has been demonstrated not to interfere with the immune response, meaning that it did not induce unintended immunosuppression or enhancement.

Cytopoint functions like naturally occurring antibodies and is eliminated via normal protein degradation pathways in the same way, with minimal involvement of the liver or kidneys.

 

Cytopoint Prescribing Information

The recommended minimum efficacious dose for the treatment of clinical manifestations of atopic dermatitis in dogs is 1 mg/kg, which can be repeated monthly. Cytopoint will be available in single dose vials containing 10, 20, 30 or 40 mg/kg of lokivetmab.

 

About Atopic Dermatitis

Itching is among the most frequent complaints of pet owners, affecting roughly one in six dogs whose owners seek veterinary help.1 There are a number of factors that can trigger an itch reaction, such as infections, allergies and parasites – and approximately 15 to 20 percent of all itchy dogs will be diagnosed with atopic dermatitis.

Cytopoint has been available since July to veterinary dermatology specialists through an early experience program and to veterinarians in EU countries in the fall. It brings mAb therapy – a fast-growing area in human medicine – for the first time to veterinarians for use to treat atopic dermatitis in canine patients.

 

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, future operating or financial performance, expectations regarding products, and other future events. 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, 2016, 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 Data on file, IL-31 Positioning Research.  IPSOS 2014. IL-31 Pricing Research. SKP. 2015, Zoetis LLC.