March 22, 2016
One day after earning its first FDA drug approval, Aratana Therapeutics Inc. announced pursuit of a second.
The Leawood, Kan., company reported Monday that the U.S. Food and Drug Administration signed off on Galliprant (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs. Commercial sales are expected to begin in the fall.
In the meantime, Aratana moved ahead today with the filing of an administrative New Animal Drug Application (NADA) for Entyce (capromorelin oral solution) for stimulating canine appetites. If approved, the drug could be launched late this year.
Aratana described Entyce as a ghrelin agonist and “a first-of-its-kind therapeutic to treat inappetence in dogs.”
“The therapeutic is a flavored, oral liquid prescription that works by mimicking ghrelin, the hunger hormone, to stimulate appetite,” the company added.
“Our market research indicates that millions of dogs with inappetence are treated off-label with drugs, special diets and homeopathic remedies,” said Ernst Heinen, DVM, Ph.D., Aratana’s chief development officer. “The anticipated FDA approval of Entyce would make it the only therapeutic approved for use by veterinarians to fulfill a serious unmet need for dogs that have stopped eating.”
The company’s first approved drug, Galliprant, works by blocking prostaglandin E2 (PGE2)-elicited pain and inflammation.
“Clinical studies have shown Galliprant offers proven efficacy when compared to placebo and is well-tolerated in dogs,” said President and CEO Steven St. Peter, M.D.
Galliprant may be used in most dogs at least 9 months old and weighing a minimum of 8 pounds. Possible adverse reactions, according to Aratana, include vomiting, diarrhea and decreased appetite.
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