Vanda slams FDA rejection of gastroparesis drug

The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.

In a statement, the company says the FDA's decision is "conclusory", disregarding the evidence submitted in support of the drug, and asked for additional studies to be run "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."

It also accuses the regulator of dragging its heels on the review of the neurokinin-1 receptor (NK-1R) antagonist, which was delayed by more than 185 days, and ignoring requests to convene an advisory committee meeting to review tradipitant's application.

"Despite this disappointing action by the FDA, Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard with a favourable benefit-risk profile for the treatment of patients with gastroparesis," said the company.

It also said that some patients with gastroparesis – a potentially serious condition that can cause severe nausea, vomiting, eating difficulties, and pain – have filed a Citizen's Petition urging the FDA to approve tradipitant, which would have ended a 40-year drought in new therapies for the disorder if approved.

Gastroparesis is most commonly associated with diabetes, but is also seen as a complication of other diseases and is also a recognised side effect of GLP-1 agonists used to treat diabetes and for weight loss. It is estimated to affect around 6 million people in the US.

Vanda has insisted it will continue to seek approval for tradipitant, which is also in late-stage clinical testing for motion sickness with a marketing application expected before the end of this year.

Shares in Vanda slid after the news emerged, although the stock has been volatile in recent months as the company fended off a pair of takeover attempts – from Cycle Pharma and Future Pak – which offered upwards of $8 per share for the business. At the time of writing the stock was trading at $4.62.

Vanda's revenues have been under pressure in the last couple of years, but it is expecting an uptick in its fortunes after a key approval for antipsychotic Fanapt (iloperidone) in bipolar I disorder, extending its use beyond schizophrenia, and the planned launch later this year of Ponvory (ponesimod) for relapsing forms of multiple sclerosis.

Tradipitant has been seen as another key driver for sales growth, with analysts at Jefferies previously suggesting it could become a $900 million product in gastroparesis alone, but for now that is off the table. Vanda predicted 2024 revenues of $180 to $210 million in its second-quarter results update.

Image by Martin Büdenbender from Pixabay