WASHINGTON, Feb. 5, 2019 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) has filed a complaint against the
U.S. Food and Drug Administration (the 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 a non-binding recommendation that nine-month non-rodent
toxicity studies should be conducted before a drug is studied in
humans for longer than three months as a non-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, a six-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.
"We believe that there is no scientific justification
for the requirement that tradipitant be tested in a
nine-month dog study, given its currently understood safety profile
in both animals and humans, and further, that these studies should
not be a routine requirement for all sponsors," said Mihael H. Polymeropoulos, M.D., Vanda's
President and CEO. "The FDA is ignoring a large body of
published scientific evidence which concludes that these
chronic dog studies do not offer any additional useful
information. That policy is based on old, outdated science
and requires the killing of too many dogs without
any scientifically justified purpose. Yet, companies
have been reticent to stand up to the FDA and demand that it change
its policy. Vanda is unwilling to accept the status quo."
Vanda proposes that the FDA has violated the law by making
nine-month dog toxicity studies a de facto
requirement, with the threat of severe consequences, such as a
clinical hold and the threat of civil injunction or criminal
prosecution, if disregarded, without promulgating this
"requirement" as a regulation under the required notice-and-comment
rulemaking procedures. Federal government agencies must
propose regulations and solicit comments from the public before
they are finalized and treated as binding, but the FDA failed to
follow that procedure here.
"We believe that we have an ethical responsibility to reduce,
refine and replace animal experimentation to the maximum extent
possible," said Dr. Polymeropoulos. "While the FDA purports to
aspire to the same goals, its refusal to entertain alternatives to
a nine-month dog study based on tradipitant's efficacy results to
date, clean safety record, and the unmet medical need for
gastroparesis treatments, suggests otherwise."
Along with filing the lawsuit, Vanda has released an open letter
(here) urging others to join the company in demanding that
the FDA review and revise its outdated policy.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda is a global biopharmaceutical company focused on the
development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com.
MEDIA CONTACTS:
AJ Jones II
Burson Cohn & Wolfe (BCW)
1110 Vermont Avenue, NW, Suite 1200
Washington, D.C. 20005
202-530-0400
pr@vandapharma.com
Elizabeth Van Every
Burson Cohn & Wolfe (BCW)
230 Park Avenue South
New York, NY 10003
212-614-3881
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.