Kindred Biosciences, Inc, a biopharmaceutical company focused on saving and improving the lives of pets, has received a technical section complete letter for effectiveness from the US Food and Drug Administration’s Center for Veterinary Medicine for Zimeta (dipyrone injection) approving the technical section.
The basis for this complete letter was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses to assess the effectiveness of Zimeta. The primary endpoint was improvement (a 2°F or greater decrease in temperature from baseline) or resolution of fever (a return to normothermia (=101.0°F)) at hour 6 following treatment. One hundred and thirty-seven horses (103 Zimeta and 34 control product) were included in the statistical analysis for effectiveness. At 6 hours post-treatment, the success rate was 74.8% (77/103) of Zimeta-treated horses and 20.6% (7/34) of control horses. The results of the field study demonstrate that Zimeta administered at 30 mg/kg intravenously was effective for the control of pyrexia 6 hours following treatment administration.
Richard Chin, CEO of KindredBio, stated, “This is a major milestone for KindredBio, and it is a testament to the strength of the data that it was reviewed by the FDA so rapidly. The entire clinical programme, from initiation of enrollment in the pivotal field study to the receipt of the complete letter, was only 18 months, highlighting the quality of our team and investigators. We look forward to the launch of the first FDA-approved drug for fever in horses, a condition that affects millions of horses every year.”
KindredBio has responded to the first round of review by the FDA for the CMC technical section. KindredBio is in the process of responding to the first round of review by the FDA on the safety technical section. KindredBio expects the approval of Zimeta in the first half of 2017 if the FDA review process is rapid.