By Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration has approved Elanco Animal Health (NYSE:ELAN)’s skin disease treatment for dogs, the health regulator’s website showed on Thursday.
The oral drug, Zenrelia, aims to control pruritus, or itching, associated with allergic dermatitis and to control atopic dermatitis in dogs at least 12 months of age.
Zenrelia, an immunosuppressant, is administered once daily, with or without food.
Elanco considers Zenrelia as one of its potential blockbusters. It is the company’s first product in the market for skin disease treatments in dogs, which already has products such as Zoetis (NYSE:ZTS)’ oral treatment Apoquel.
The company plans to launch the drug in the coming days, Elanco CEO Jeff Simmons told Reuters.
Zenrelia belongs to a class of drugs known as JAK inhibitors, which block inflammation-causing enzymes known as Janus kinases.
In June, the company cautioned that the boxed warning on the drug label could slow its adoption in the U.S.
The FDA approval for Zenrelia carries a boxed warning stating that dogs should not be vaccinated at least 28 days before and after treatment with the drug, due to the risk of fatal vaccine-induced disease and inadequate immune response to vaccines.
Shares of the company rose 3% in afternoon trade.