We asked Dr. Stephen Sutherland, Anivive’s Chief Regulatory Affairs Officer, why it is that there are so few drugs approved specifically for veterinary use.
What is the Main Reason We Don’t Have More Therapeutics for Companion Animals?
Easily put, the economic incentive isn’t there like it is for human drugs. The process to develop and approve a drug is extensive for both humans and animals, and it takes just as long to get approval on a drug for small market use as it does for larger market use. On average, it takes 7-10 years to develop and approve a new animal drug and up to $100 million. A lot of companies do not think it’s worth the time to develop a new drug for animals who have a shorter life span than humans.
Why Does it Cost So Much to Develop a New Drug?
The process to develop any drug, human or animal, is long and rigorous. There are many steps to get from test tube to prescription, including safety and efficacy trials and the extensive FDA regulatory review process. Additionally, there are challenges in running field studies that must strictly adhere to complex study designs. Gathering enough diseased participants that fit the required entrance criteria and monitoring these animals over long periods is labor intensive and costly.
Are There Any Differences in the Animal versus Human Drug Development Processes?
The regulatory requirements for animal and human drugs are very similar. Both require FDA approval and submission of extensive efficacy, safety, and manufacturing data. The journey to approval involves many different trials and stages. Animal drug approval requires a double-blind effectiveness study, just as human drug approval does. The main difference is the number of participants required—thousands of human participants are typically needed for human drug approval, compared with hundreds needed for animal drug approval.
Who Does This Impact the Most?
The lack of drugs specifically approved for animal use most directly impacts veterinarians who rely on their education and medical experience to identify and prescribe appropriate therapeutic drugs for an extremely diverse array of disease conditions. The lack of FDA approved animal drugs to treat these conditions forces veterinarians to utilize drugs that are only approved for humans. This is especially true for animals that have rare conditions as drug development costs cannot be recovered due to the limited demand for the drugs.
What is Anivive Lifesciences Doing to Try to Bring More Therapeutics Designed Specifically for Companion Animals to Market?
Anivive is using technology to decrease development costs. At the beginning of the development process, we use AniviveSELECT, a giant database of drug data that uses machine learning to do gene homology research, including analyzing human drugs to identify compounds that could be effective in animals. We’re also trying to speed up the clinical trial process for animal drugs using a software platform, AniviveTRIAL, designed to make it easier for veterinarians and pet owners to find and participate in clinical trials.