WASHINGTON, Sept. 19,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today provided an update on its tradipitant
development program.
On September 18, 2024, the U.S.
Food and Drug Administration (FDA) declined to approve Vanda's New
Drug Application (NDA) of tradipitant for the treatment of symptoms
in gastroparesis, providing Vanda with a Complete Response Letter
(CRL).
Gastroparesis is a serious condition that is characterized by
delayed gastric emptying and associated with severe nausea,
vomiting, difficulty finishing a normal meal and other symptoms
that have a significant impact in people's everyday living and
functioning. Gastroparesis is often associated with diabetes but is
also found in nondiabetic individuals and has recently been
associated with the class of GLP1 inhibitors. There has been no
effective treatment approved by the FDA in over 40 years.
Vanda's tradipitant application included evidence from two
placebo-controlled studies, the results of which were published in
peer review journals.1,2 The evidence of efficacy was
further supported by exposure response data from a large open label
study as well as the real world experience of dozens of patients
treated in an expanded access program, some for several years.
The CRL was conclusory in nature, generally disregarded the
evidence provided and instead suggested that Vanda conduct
additional studies with a design and duration inconsistent with the
advice of key experts in the field and not appropriate based on the
scientific understanding and natural course of the
disorder.
Furthermore, the FDA's action was delayed by more than 185 days
and fails to satisfy the requirements specified by the Food Drug
and Cosmetic Act (FDCA). The FDCA requires that the FDA review a
new drug application and within 180 days of submission provide
either an approval or an opportunity for a hearing. In this case
the FDA failed to do either.
Despite this disappointing action by the FDA, Vanda
believes that the tradipitant application has met the substantial
evidence of efficacy standard with a favorable benefit risk profile
for the treatment of patients with gastroparesis. While Vanda
has repeatedly requested that the FDA convene an expert advisory
committee to review the application and advise the Commissioner on
the approvability of this application, the FDA has refused to do
so. A number of patients currently treated with tradipitant have
filed a Citizen Petition urging FDA to approve tradipitant for the
treatment of gastroparesis.
Vanda will continue to pursue the marketing authorization for
tradipitant and will continue to support the expanded access
program that is currently serving several dozen patients with
gastroparesis. Vanda encourages any patients with questions about
expanded access to contact us at the following email address
ExpandedAccess@vandapharma.com.
Vanda plans to submit a separate NDA for tradipitant for the
prevention of vomiting in motion sickness later this year.
About Vanda Pharmaceuticals Inc.
Vanda is a leading 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 and follow us on X @vandapharma.
References
- Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A.,
Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P.,
Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H.
(2024). The efficacy of tradipitant in patients with diabetic and
idiopathic gastroparesis in phase III randomized placebo-controlled
clinical trial. Clinical Gastroenterology and Hepatology.
Available online:
https://www.cghjournal.org/article/S1542-3565(24)00050-8/fulltext
- Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao,
C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H. P., &
Polymeropoulos, M. H. (2021). Efficacy and Safety of Tradipitant in
Patients With Diabetic and Idiopathic Gastroparesis in a
Randomized, Placebo-Controlled
Trial. Gastroenterology, 160(1), 76–87.e4.
Available online: https://doi.org/10.1053/j.gastro.2020.07.029
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to, statements regarding Vanda's plans for pursuit of
FDA approval of tradipitant for the treatment of symptoms of
gastroparesis and motion sickness are "forward-looking statements"
under the securities laws. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. Forward-looking statements are based upon current
expectations and assumptions that involve risks, changes in
circumstances and uncertainties. Important factors that could cause
actual results to differ materially from those reflected
in Vanda's forward-looking statements include, among others,
Vanda's ability to complete and submit to the FDA the NDA for
tradipitant for the treatment of motion sickness within the
specified timeframe and the FDA's assessment of the sufficiency of
the data packages to be included in the NDA for tradipitant.
Therefore, no assurance can be given that the results or
developments anticipated by Vanda will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Forward-looking statements
in this press release should be evaluated together with the various
risks and uncertainties that affect Vanda's business and market,
particularly those identified in the "Cautionary Note Regarding
Forward-Looking Statements", "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's most recent Annual Report on Form
10-K, as updated by Vanda's subsequent Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this press release is
provided only as of the date of this press release, and Vanda
undertakes no obligation, and specifically declines any obligation,
to update or revise publicly any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.