- Mirataz would be the first and only medication approved in the EU to treat cats experiencing poor appetite and weight loss resulting from chronic medical conditions.
San Francisco, California (October 10, 2019) – Kindred Biosciences, Inc. (Nasdaq: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a positive opinion recommending marketing authorization of Mirataz® (mirtazapine transdermal ointment) for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Furthermore, KindredBio announced that it recently filed for regulatory approval of Mirataz in Canada.
“Today’s positive CVMP opinion marks a key achievement for KindredBio. Europe is the second largest market for veterinary therapeutics globally. As the first medication expected to be approved for poor appetite and weight loss in cats in the EU, we are once again at the forefront of addressing unmet needs in veterinary medicine. This anticipated approval provides further validation of our rapid and cost-efficient development model,” said Richard Chin, Chief Executive Officer of KindredBio. “We expect European uptake of Mirataz to benefit from regulations prohibiting use of human medicine once an approved veterinary therapeutic is available.”
If approved in the European Union, Mirataz would be the first and only medication approved to induce bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Weight loss is a leading cause of visits to the veterinarian for cats in Europe.
A marketing authorization decision from the European Commission is anticipated within approximately two months. Regulatory approval is subject to the typical risks inherent in such a process. If approved, the authorization will be valid in all 28-member states of the European Union, as well as Iceland, Liechtenstein, and Norway. In Canada, the validation of the Canadian submission will be complete in the next 30 to 45 days and once accepted for review, the review timeline is approximately one year.
The CVMP’s positive opinion is based on results from both clinical and non-clinical studies. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing poor appetite and weight loss from chronic medical conditions. In clinical studies, Mirataz resulted in significant weight gain in cats in as little as 14 days following topical application of 2 mg per day . Mirataz, which is formulated with KindredBio’s proprietary Accusorb™ technology, is applied topically to the cat’s inner ear (pinna) once a day, providing a different application route compared to oral administration.
Mirataz was approved by the U.S. Food & Drug Administration in May 2018 for the management of weight loss in cats.
 Mirataz® (mirtazapine transdermal ointment) [package insert], Kindred Biosciences, Inc. (Burlingame, CA). Rev. 5/2018.
Important Safety Information
Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application. The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.
About Kindred Biosciences
Kindred Biosciences is a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.
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