United States

Zoetis Receives New Allergic Dermatitis Indication for Cytopoint®

First monoclonal antibody (mAb) licensed for the treatment of allergic and atopic dermatitis in dogs


PARSIPPANY, N.J. – Sept. 14, 2018Zoetis today announced that the U.S. Department of Agriculture (USDA) has granted an expanded indication for Cytopoint®, a novel monoclonal antibody (mAb) therapy for the treatment of allergic dermatitis in dogs. Cytopoint is the first mAb therapy licensed to treat allergic as well as atopic dermatitis, an indication for which it was fully licensed by the USDA in 2016. Administered every four to eight weeks, one injection of Cytopoint works by targeting and neutralizing interleukin-31 (IL-31), a key protein involved in triggering itch in dogs, offering both convenience and sustained efficacy.

“This approval gives veterinarians much needed flexibility for personalized treatment of allergic and atopic dermatitis in dogs with two therapeutic approaches – the injectable Cytopoint and the oral tablet Apoquel,” said Thomas P. Lewis II, DVM, DACVD, Dermatology for Animals in Gilbert, Arizona.* “Allergic dogs and their owners have a variety of needs, and these medications from Zoetis can bring fast and long-lasting relief to my canine allergy patients, as well as bring peace of mind to their owners.”

Apoquel® (oclacitinib tablet) starts relieving itch within four hours and provides veterinarians with the flexibility to start and stop itch control, which is beneficial for assessments during the diagnostic work-up.1-3 Cytopoint begins to relieve itch within 24 hours and provides sustained itch relief for four to eight weeks, giving the skin time to heal.4 Cytopoint and Apoquel may be used together to manage intermittent flare of pruritus due to fleas, food or seasonal factors.  Both therapies protect the bonds that matter most – the human-animal bonds. 

“Zoetis strives to advance the treatment of dogs with canine pruritus,” said Andrew Hillier, BVSc, MANZCVS, DACVD, Veterinary Specialty Operations and Veterinary Medical Lead – Dermatology for Zoetis. “We know that itch can erode cherished bonds and can take an emotional toll on owners. With this new Cytopoint indication for allergic dermatitis, veterinarians have another option to provide relief for their pruritic patients as they are going through the diagnostic process.” 

For more information on the new indication for allergic dermatitis, visit www.cytopoint.com.

About Cytopoint
Cytopoint is a ready-to-use, sterile liquid injectable containing a mAb specifically designed to target and neutralize cytokine interleukin-31 (IL-31), a key cytokine (protein important in cell to cell communication) involved in triggering the itch associated with canine atopic dermatitis and allergic dermatitis. Cytopoint 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 1 day and delivers 4 to 8 weeks of relief from the clinical signs of canine allergic and atopic dermatitis, allowing damaged skin the chance to heal. In a clinical study supporting efficacy in atopic dermatitis, treatment with Cytopoint at a minimum dose of 2 mg/kg resulted in a significantly (P≤0.05) greater percentage reduction from baseline in pruritus on days 1 – 49, and skin condition scores on days 7-565, when compared to placebo.  In a laboratory animal study using the IL-31-induced model of pruritus, treatment with Cytopoint at a dose of 2 mg/kg had significantly (P<0.0001) lower pruritus scores at assessment days 1 and 28 when compared to placebo.6

It is safe for dogs of any age, even those with concomitant diseases, and can be used with many common medications. Moreover, because of its specificity in targeting IL-31, it has minimal impact on normal immune responses.

IMPORTANT SAFETY INFORMATION ABOUT APOQUEL
Do not use Apoquel in dogs less than 12 months of age or those with serious infections. Apoquel may increase the chances of developing serious infections and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Apoquel has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel has been used safely with many common medications including parasiticides, antibiotics and vaccines. For full Prescribing Information, go to ZoetisUS.com/ApoquelPI.

About Zoetis
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. 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 2017, the company generated annual revenue of $5.3 billion with approximately 9,000 employees. For more information, visit www.zoetisUS.com.

* Dr. Thomas P. Lewis II has a consulting relationship with Zoetis.

References:
1Gadeyne C, Little P, King VL, et al. Efficacy of oclacitinib (Apoquel®) compared with prednisolone for the control of pruritus and clinical signs associated with allergic dermatitis in client-owned dogs in Australia. Vet Dermatol. 2014;25(6):512-518. doi:10.1111/vde.12166.
2Cosgrove SB, Cleaver DM, King VL, et al. Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life. Vet Dermatol. 2015;26(3):171-179. doi:10.1111/vde.12194.
3Aleo MM, Galvan EA, Fleck JT, et al. Effects of oclacitinib and prednisolone on skin test sensitivity [abstract]. Vet Dermatol. 2013;24(3):297.
4Data on file, Study Report No. C863R-US-12-018, Zoetis Inc.
5Data on file, IL-31 Positioning Research.  IPSOS 2014. IL-31 Pricing Research. SKP. 2015, Zoetis LLC.
6Data on file, Study Report No. C166R-US-17-180, Zoetis Inc.

For further information contact:
Colleen White 
Zoetis 
973-822-7203 (o)
colleen.white@zoetis.com

Danielle Paleafico
Coyne PR
973-588-2184 (o)
dpaleafico@coynepr.com