Exhibit 99.1
Vanda Pharmaceuticals Takes a Stand Against Unnecessary Animal Research
Company pursuing legal action against the FDA for requiring unnecessary studies that would result in the death of dozens of dogs without legal authority.
Washington, DC – February 5, 2019 — Vanda Pharmaceuticals Inc. has filed a complaint against the U.S. Food and Drug Administration (FDA) requesting that the court lift a partial clinical hold the agency illegally imposed prohibiting Vanda from studying a promising new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal studies.
Vanda has taken this legal action as it works through the FDA development process for tradipitant, a potential treatment for several human conditions including gastroparesis.
During the course of drug development, animal studies are routinely conducted to identify potential toxicities in humans. FDA guidance documents outline the types of animal studies, including the appropriate species and duration, that are recommended to provide sufficient evidence of safety before a drug is studied in humans. However, the recommendations in FDA guidance documents are not legally binding on either the FDA or drug developers. If a company submits information to the FDA to show that further study in humans would be safe based on different information, the FDA is supposed to evaluate the company’s proposal and make a case-specific, science-based determination as to whether it agrees.
In Vanda’s case, the FDA did not do so. It has instead treated anon-binding recommendation that nine-monthnon-rodent toxicity studies should be conducted before a drug is studied in humans for longer than three months as anon-negotiable requirement. Solely because Vanda has refused to conduct this study, which usually involves young beagles as the test subjects, each of which must be “sacrificed” to permit evaluation of the animal’s tissues, the FDA has placed a partial clinical hold on Vanda’s studies of tradipitant. Tradipitant studies can proceed up to 12 weeks duration. The FDA has imposed this partial hold without providing any specific scientific justification. As a matter of law, the FDA is not permitted to do that. As a result, Vanda has sued in federal court for judicial relief.
Numerous preclinical animal studies have already been conducted with tradipitant, including a three-month rat study, asix-month rat study and a three-month dog study, at doses up to 300 times the intended human equivalent dose. These studies have not identified any clinically relevant safety signals for humans. Clinical studies of tradipitant in humans have also suggested that tradipitant is well-tolerated, as have clinical and preclinical studies of drugs in the same class as tradipitant. In addition, scientific literature has shown that nine-month studies in dogs are unlikely to identify clinically relevant safety signals that are not already identified in three-month studies.
