Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration’s Center for Veterinary Medicine for Mirataz (mirtazapine transdermal ointment) approving the technical section.
The basis for this complete letter was a multicenter, randomized, double-blind, placebo-controlled pivotal field study that enrolled 230 cats to assess the effectiveness of Mirataz in managing weight loss in cats. The primary endpoint was mean percentage change in body weight from Day One to Week Two. At Week Two, the mean percent increase in body weight from Day One was 3.94 percent in the Mirataz group (n=83), compared to 0.41 percent in the placebo group (n=94) (p<0.0001). Based on a preliminary review of the safety data, the drug appears to be well tolerated.
“This is a major milestone for KindredBio, and it is a testament to the quality of the submission and the significant unmet medical need that it was reviewed by the FDA in a single cycle and ahead of the standard (ADUFA) timelines,” Kindred Bio CEO Richard Chin said. “We look forward to the launch of the first FDA-approved drug for the management of weight loss in cats, the most common reason for feline veterinary visits in United States. We expect the approval of Mirataz in the second half of 2017 assuming no unforeseen delays in the review process.”