Aratana Therapeutics Inc. is asking for U.S. and European approvals of a treatment for osteoarthritis pain and inflammation in dogs. Prompt action from the U.S. Food and Drug Administration’s Center for Veterinary Medicine could lead to Galliprant (grapiprant tablets) being made available to veterinarians this fall, according to the Leawood, Kan., company. An administrative New Animal Drug Application—the company’s first—was filed in late January. Aratana reported Wednesday that a marketing authorization application for Galliprant was submitted to the European Medicines Agency. If the agency and the European Commission approve the application, the therapeutic could be released overseas as early as 2017. The company described Galliprant as a “first-in-class piprant” that binds to the EP4 prostaglandin receptor antagonist on the PGE2 pathway to block pain and inflammation. “If approved, Galliprant will offer veterinarians a new option to treat dogs with osteoarthritis pain," said chief development officer Ernst Heinen, DVM, Ph.D. Five-year-old Aratana also announced that Tactress, a monoclonal antibody formulated for use in dogs with T-cell lymphoma, earned full licensure from the U.S. Department of Agriculture’s Center for Veterinary Biologics. Another product, Blontress, which is used to treat canine B-cell lymphoma, has a full USDA license as well. Aratana has invested heavily in research and development as it explores a number of pet therapeutics, including possible solutions for inappetence, viral diseases and allergies. The company’s third-quarter financial report revealed a modest jump in revenue—a total of $615,000 in the first nine months—and a net loss of $71.2 million over the same period.
