FDA Promotes Development and Marketing of Drugs for Rare Diseases in Animals

Research shows that more than half of US households keep pets, and this number is likely to increase as people continue to be isolated, stay at home, or seek the mental and physical benefits associated with pet ownership during the COVID-19 outbreak.  With ownership comes responsibility for the welfare of pets; however, healthcare can be only as good as the available diagnostic tools and treatments. Beyond routine checkupsand the diagnosis and treatment of common diseases in animals, veterinary medicine often uses drugs and devices to diagnose and treat rare diseases.

Through the Minor Use/Major Species (MUMS) pathway, the U.S. Food and Drug Administration (FDA) recently granted conditional approval to AniviveLifesciences Inc. for verdinexor (Laverdia-CA1) tablets as a treatment for canine lymphoma, a disease that affects fewer than 70,000 dogs in the U.S. each year. Its MUMS program provides financial and other incentives to sponsors for developing new animal drugs for use in minor and major species.

While FDA’s conditional approval allows veterinary drug manufacturers up to five years to continue to collect the effectiveness data necessary for full approval, there is no exclusivity, so another sponsor could get their product approved for the same drug/formulation/intended use and the conditionally-approved product would have to be withdrawn.  Through MUMS program, the FDA has provided a pathway that will encourage veterinary drug manufacturers to continue developing and marketing drugs for minor use in major species and for minor species applications.