Media Coverage

KindredBio pivotal results bring Zimeta closer to approval

Dec 05, 2017 - Animal Pharm
By Joseph Harvey
Animal Pharm
December 5, 2017

Kindred Biosciences has moved a step closer to US authorization of Zimeta (dipyrone oral gel) for the control of pyrexia in horses. 

The Californian business secured positive topline results from a pivotal field effectiveness study of Zimeta. The multicenter, randomized, blinded, placebo-controlled pivotal study enrolled 139 horses to assess the effectiveness of Zimeta Oral.

"The primary endpoint was improvement or resolution of fever six hours after treatment," the firm stated. "The success rate was approximately 78% in the Zimeta Oral group versus approximately 18% in the placebo group (p=0.0026). Based on preliminary review of the safety data, the drug appears to be well tolerated."

Following these results, KindredBio has completed the in-life portion of its Target Animal Safety Study and is currently analyzing the data. The company said it now anticipates submitting the effectiveness technical section of the New Animal Drug Application (NADA) to the US FDA in early 2018, while the safety and chemistry, manufacturing and controls (CMC) technical sections will be submitted in the first half of 2018.

KindredBio has not yet given any guidance regarding the anticipated timeline for Zimeta Oral's US approval. The company told Animal Pharm it will be in a better position to make a prediction once all of the major technical sections of the NADA have been submitted.

However, the company is expecting US approval for Zimeta IV (dipyrone injection) in the first half of 2018.

Richard Chin, the firm's president and chief executive, said: "This is our third consecutive, positive pivotal study and demonstrates KindredBio's ability to rapidly and successfully develop products. With the caveat that the safety and CMC data are still pending, we look forward to bringing this important medicine to patients. With Zimeta IV under review with the FDA, the potential to add Zimeta Oral to the treatment paradigm will allow us to realize the full market potential for controlling fever in horses."

Currently, KindredBio is ramping up its production capacity and commercialization efforts for forthcoming product approvals

Reprinted with permission of Animal Pharm News




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