FDA Rejects Vanda's Tradipitant Application for Gastroparesis

On September 19, 2024, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced an important update regarding its development program for tradipitant. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on September 18, 2024, declining to approve Vanda's New Drug Application (NDA) for tradipitant intended to treat gastroparesis symptoms.

Gastroparesis is a significant condition marked by delayed stomach emptying, leading to severe nausea, vomiting, and difficulties in consuming normal meals. It severely affects the quality of life and daily functioning of those afflicted. While the condition is commonly linked to diabetes, it can also occur in individuals without diabetes and has recently been associated with GLP1 inhibitors. Notably, the FDA has not approved an effective treatment for gastroparesis in over four decades.

Vanda's application for tradipitant was backed by data from two placebo-controlled studies, with results published in reputable peer-reviewed journals. Additionally, evidence of the drug's efficacy was bolstered by data from a large open-label study and real-world experiences from numerous patients treated under an expanded access program, some for several years.

The CRL, however, largely dismissed the provided evidence. It recommended that Vanda conduct further studies with a design and duration inconsistent with the guidance from key experts and inappropriate given the existing scientific understanding and natural progression of the disorder. Moreover, the FDA's response was delayed by over 185 days, failing to meet the Food Drug and Cosmetic Act (FDCA) requirements. According to the FDCA, the FDA must review a new drug application within 180 days of submission and either approve it or offer an opportunity for a hearing. In this case, the FDA did neither.

Despite this setback, Vanda remains confident that its tradipitant application meets the substantial evidence of efficacy standard and has a favorable benefit-risk profile for treating gastroparesis patients. Vanda has persistently requested that the FDA convene an expert advisory committee to review the tradipitant application and advise the Commissioner on its approvability, but the FDA has not agreed to this request. In response, several patients currently using tradipitant have filed a Citizen Petition, urging the FDA to approve the drug for gastroparesis treatment.

Vanda is determined to continue pursuing marketing authorization for tradipitant and will maintain support for the expanded access program currently benefiting dozens of gastroparesis patients. Vanda also plans to submit a separate NDA for tradipitant aimed at preventing vomiting in motion sickness later this year.

Vanda Pharmaceuticals Inc. is a leading global biopharmaceutical company focused on developing and commercializing innovative therapies to meet high unmet medical needs and enhance the lives of patients.