Complete Response Letter for tradipitant to treat gastroparesis

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. 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.