GREENFIELD, Ind. – Elanco Animal Health (NYSE:) Incorporated (NYSE: ELAN) has received U.S. Food and Drug Administration approval for Zenrelia™, a new once-daily oral JAK inhibitor designed to treat pruritus associated with allergic dermatitis and control atopic dermatitis in dogs at least 12 months of age. The announcement comes as Elanco enters the global canine dermatology market, currently estimated at $1.7 billion.
Zenrelia is positioned to offer an alternative to the current market incumbent, Apoquel® (oclacitinib tablet), with a head-to-head study indicating that Zenrelia achieved clinical remission of itch in 77% of treated dogs compared to 53% with Apoquel. This study, conducted across 25 sites in four countries, suggests Zenrelia offers greater relief from itch and skin lesions over time.
The product is expected to ship in the United States in the coming days, with Elanco stating that Zenrelia will be more affordable for pet owners, offering a 20% lower list price for nearly all dogs compared to Apoquel. The company also emphasizes the convenience of once-daily dosing and the minimized risk of “rebound itch,” which is often observed with other treatments.
Safety studies for Zenrelia have been conducted, including a six-month trial in healthy dogs, with no serious adverse events reported. However, the label includes a boxed warning about the risk related to concurrent vaccine administration, based on a study where two immunosuppressed dogs were euthanized. Veterinarians are advised to ensure dogs are up to date on vaccinations before starting treatment with Zenrelia.
Elanco’s President and CEO, Jeff Simmons, expressed confidence in Zenrelia’s ability to meet the needs of veterinarians and pet owners, and the company plans to further investigate the drug’s effects on vaccine response in treated dogs.
As this news is based on a press release statement, investors and interested parties can expect further details from Elanco’s conference call scheduled for Friday, September 20, 2024, at 8:00 am Eastern Time.
The approval of Zenrelia marks Elanco’s entry into the canine dermatology market, with the potential to provide a new standard of care for millions of dogs suffering from dermatological conditions.
In other recent news, Elanco Animal Health Incorporated reported a strong financial performance in the second quarter of 2024, with significant revenue, adjusted EBITDA, and adjusted EPS growth. The company also secured a new $350 million…
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