Kindred Biosciences gets early approval of effectiveness technical section from US FDA for Mirataz
Kindred Biosciences, a biopharmaceutical company focused on saving and improving the lives of pets, has announced it has received a technical section complete letter for effectiveness from the US 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 1 to Week 2. At Week 2, the mean percent increase in body weight from Day 1 was 3.94 per cent in the Mirataz group (n=83), versus 0.41 per cent 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.
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