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

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[co-authors: Gloria Malpass, Ph.D., Heather Hatcher, Ph.D., and Lane Songer, RN, BSN, DVM]

Market 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 checkups, preventative medicine, and 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 Anivive Lifesciences 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. Similar to the FDA’s Orphan Products Development (OOPD) program that advances the evaluation, development, and marketing of drugs, biologics and medical device products to diagnose and/or treat rare diseases in humans, the MUMS program provides financial and other incentives to sponsors for developing new animal drugs for use in minor species (e.g., zoo animals, parrots, ferrets, and guinea pigs) or for use in major species (dogs, cats, horses, cattle, pigs, turkeys, and chickens) afflicted with uncommon diseases or conditions (minor uses). For veterinary drugs, MUMS designation makes the sponsor eligible for the following: waiver of all fees (unless the sponsor is already paying them); grants to help pay for studies, including safety and effectiveness testing; and seven years of exclusive marketing rights beginning on the day of the drug approval or conditional approval. This exclusivity protects the intended use of the product from generic copying and other new animal drugs for the same drug/dosage form/intended use.

Since Laverdia-CA1 is an oral treatment, dog owners can administer the drug to dogs while following the veterinarian prescription and safety directions at home. Minor Use/Minor Species drugs need to meet all the same requirements as major species do for drug approval. For information about the drug approval process for MUMS uses, see FDA’s website and Guidance for Industry #61.

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 (unless designated), 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.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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