FDA Approves Equine Lameness Drug

Tildren (tiludronate disodium) is an intravenous solution for the treatment of the most common cause of chronic forelimb lameness in horses.

Tildren is indicated for the treatment of navicular syndrome.

Ceva Animal Health has brought to the United States a drug that earned wide support around the world for the treatment of navicular syndrome in horses.

Tildren (tiludronate disodium) went on sale on U.S. soil this month after winning approval from the U.S. Food and Drug Administration. More than 250,000 doses of the intravenous solution have been administered worldwide over the past 12 years, Ceva announced today.

Ceva earlier this year launched a U.S. equine division, promising drugs such as Tildren, the estrus suppressant Altresyn (altrenogest) and the stress reducer ConfidenceEQ.

Some U.S. equine veterinarians knew about Tildren but couldn’t obtain it without a special import agreement, Ceva noted.

“The approval of Tildren by the FDA provides veterinarians and horse owners an excellent new tool for managing navicular syndrome,” said Steve Hoffman, vice president of Ceva’s equine business unit.

Navicular syndrome is the most common cause of chronic forelimb lameness in horses, the company noted. Tildren is formulated to regulate osteoclasts in areas of excessive activity.

“In navicular syndrome, excessive mechanical stress results in bone resorption outpacing bone formation,” Ceva added. “Tildren works at areas of active bone resorption, restoring balance to the process of bone remodeling.”

Kyle Creech, DVM, Ceva’s equine veterinary services manager, called the drug a “novel therapy that can lead to successful outcomes even when clinical signs have not improved with other therapies.”

Tildren is not recommended for horses suffering from impaired renal function or with a history of renal disease, and it should not be used concurrently with NSAIDs. Its use has not been evaluated in horses less than 4 years old, in pregnant or lactating mares, or in breeding horses, according to Ceva.

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