Elanco’s dermatology treatment for itchy dogs gets FDA approval – Inside INdiana Business

Federal regulators have approved a new dermatology treatment for itchy dogs made by Elanco Animal Health Inc. that the company has touted as a potential blockbuster.

Greenfield-based Elanco said Thursday it is now taking orders for the product, called Zenrelia, and expects to start shipping it in the coming days. With the approval, Elanco will enter the estimated $1.7 billion global canine dermatology market.

Zenrelia is one of several drugs Elanco has in its pipeline that it predicts could reach blockbuster status, which in animal health means more than $100 million in annual sales.

“Itching is one of the top reasons pet owners bring their dog to the veterinarian, and pet owners and veterinarians want more canine dermatology options,” Elanco said in a written statement Thursday. “Approximately 17 million dogs suffer from allergic skin disease, including atopic dermatitis, food allergies or flea sensitivity.  Among pet owners who say their dog’s itch is not under control, 60% say they’ve tried treating the itch, but nothing works.”

Elanco called Zenrelia a safe, highly effective, once-daily tablet for dogs at least 12 months old who are suffering chronic, acute or seasonal itch and inflammation. The company said Zenrelia is a JAK inhibitor that targets the itch where it starts by blocking the pathways involved in allergic itch to break the “itch-scratch cycle.^“

“We are excited to offer veterinarians and pet owners a solution that can relieve the burdens of itch, while also becoming just the second animal health company to offer veterinarians a comprehensive portfolio, including parasiticides, vaccines, pain and other therapeutics, and now, dermatology,” said Jeff Simmons, Elanco’s president and CEO.

The Zenrelia label includes a boxed warning on safety related to concurrent vaccine administration based on the results of a vaccine response study.  Elanco said dogs should be up to date on vaccinations prior to starting Zenrelia.

“Zenrelia has been demonstrated to be safe and highly effective in a number of studies,” said Dr. Mara Tugel, veterinarian and Dermatology Medical Strategic Lead at Elanco. “We recognize that veterinarians need clinically relevant data to guide treatment choices, and plan to pursue additional studies to evaluate vaccine response in Zenrelia-treated dogs. We will continue to work to improve the label over time.”

Zenrelia will compete head-to-head with Apoquel, a JAK inhibitor made by Zoetis Inc. that was approved in 2013. Apoquel, which rang up sales of $466 million in fiscal 2020, is the top prescribed medicine for allergic itch in dogs.

Elanco said a head-to-head study found Zenrelia was at least as effective and sometimes more effective than Apoquel. The company said it would price Zenrelia about 20% lower than Apoquel.

Shares of Elanco climbed 2.87% Thursday, closing at $15.07 each.

Story Continues Below