FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
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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
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.
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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
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
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.
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202-734-3400
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