- FDA delays Vanda Pharmaceuticals' (VNDA, Financial) hearing request for tradipitant by at least six months.
- Vanda disputes FDA's reasons for the delay, citing systemic issues in the approval process.
- The FDA has not granted any new drug approvability hearing requests in at least a decade, according to Vanda.
Vanda Pharmaceuticals (VNDA) has announced a significant delay in the FDA's decision on whether to grant a hearing for tradipitant, a promising treatment for gastroparesis. The FDA has attributed this delay, expected to last at least six months, to recent staff reductions and the appointment of new Commissioner Dr. Martin Makary. However, Vanda contends that these factors should not affect the process, as Commissioner Makary confirmed that scientific staff involved in evaluations were not impacted by the cuts.
This delay is not an isolated incident for Vanda. The company has experienced similar setbacks in past applications, such as the Hetlioz drug hearing requests for jet lag and insomnia, both subjected to six-month delays. CEO Dr. Mihael Polymeropoulos is actively calling for increased transparency and rational decision-making processes within the FDA, emphasizing that such obstacles stifle innovation and delay critical treatments from reaching patients in need.
Vanda estimates that the FDA's practice of denying every hearing request related to new drug approvals for at least the past decade represents a systemic issue within the agency. The ongoing dispute has escalated to the federal level, with Vanda citing misrepresentations and unlawful actions in their appeal to see greater transparency under the oversight of Dr. Makary. This news comes as a critical blow to Vanda, especially given their market cap of $254.8 million, where regulatory efficiency is of paramount importance for maintaining development timelines and future profitability.
For more information about Vanda Pharmaceuticals and their innovative therapeutic developments, please visit their website.
