Tradipitant

“CDER is still evaluating the impact the RIF may have on CDER’s immediate operations,\" the federal department said in an April 14 letter to Vanda.\n Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the rejection of the biotech\'s stomach disorder drug last year.The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda\'s request, which was prompted by a complete response letter (CRL). In a letter to the biotech last week, the agency cited multiple reasons for the delay—including the company’s numerous ongoing legal cases with the agency, plus the recent mass federal layoffs.Vanda has filed a lawsuit against the federal agency for the \"unlawful delay\" that is currently pending in Washington, D.C., courts, a Vanda spokesperson told Fierce.   The drug at the heart of the dispute is tradipitant, an investigational NK-1R antagonist that the FDA rejected as a gastroparesis treatment in September 2024. At the time, Vanda CEO Mihael Polymeropoulos, M.D., argued that the CRL generally disregarded the evidence the company had provided to support the application.In a late-stage study (PDF), tradipitant was shown to be no better than placebo at reducing the severity of nausea across 12 weeks of treatment, but Vanda identified a baseline imbalance of rescue medication use between the treatment arms and some poor compliance with the study drug as a potential cause for the miss. When excluding patients that Vanda deemed to be confounders, the company argued that the study had actually hit its primary endpoint.After receiving the rejection, the FDA provided Vanda with a notice for the opportunity for a hearing on Jan. 7, 2025—well past the statutory deadline, according to Vanda\'s spokesperson.Despite the delay, Vanda accepted the FDA’s offer on Jan. 27 and submitted the requested information on March 17, the spokesperson told Fierce.Vanda contends it accepted the hearing offer within the required timeframe, and based on its understanding of FDA procedures, believes the agency is obligated to hold the hearing within 120 days of the notice. According to Vanda, that timeline would mean the hearing should be scheduled on or before May 7, 2025.  The FDA confirmed receipt of the submitted information on March 17 in an April 14 letter sent to Vanda from G. Matthew Warren, director of the FDA’s Office of Scientific Integrity. Warren wrote that CDER is working to thoroughly review Vanda’s submission and asked the FDA commissioner to issue a scheduling order in which CDER responds to Vanda’s request no later than Sept. 12.The FDA department cited several reasons for the proposed September deadline, with the first being that Vanda’s request for a summary judgment or hearing includes more than 15,000 pages, some of which are new materials that weren’t included in the company’s new drug application (NDA).  The timeline also considers the fact that the staffers in the Office of Immunology and Inflammation (OII) reviewing the submission are the same employees working on Vanda’s pending NDA for tradipitant in a new proposed indication of vomiting induced by motion sickness, which Vanda submitted at the end of 2024.The agency said OII workers are also providing insight related to multiple lawsuits recently filed by Vanda regarding tradipitant. These suits against the FDA include challenging timeframes by which the FDA must act; Vanda has also said that CDER tried to wait six months to respond to actions for the company’s insomnia program. Plus, Vanda is challenging a partial clinical hold related to certain tradipitant trials and contests the authority of FDA officials to review and hold a hearing on the application.Earlier this month, Vanda filed suit against the agency related to its drug Hetlioz, protesting the rules around promoting drugs’ off-label uses.In relation to Vanda, OII staff are also helping with technical review and assistance related to an ongoing tradipitant expanded access trial for gastroparesis, the letter continues.Unrelated to Vanda, the FDA\'s letter outlined CDER’s other tasks, like reviewing applications and work related to other public health issues.Finally, the health agency underscored the widespread layoffs that occurred on April 1, when President Donald Trump’s administration cut 3,500 FDA workers. This impacted CDER offices assigned to lead the review and draft the written response for this matter, according to the federal letter.“Additionally, the RIF impacted leadership of the CDER Office of New Drugs, as well as CDER (including OII) review divisions’ access to relevant subject matter experts, administrative support staff, library staff and academic journal subscriptions,” Warren wrote in the letter. “CDER is still evaluating the impact the RIF may have on CDER’s immediate operations, which may limit the speed at which the center can complete a thorough analysis of Vanda’s submission in the near term.” At the time, HHS said the FDA workforce reduction wouldn’t impact drug, medical device or food reviewers. Since then, hundreds of biotech leaders signed a letter decrying the FDA changes and detailing how it has already affected some companies.In the letter, CDER expressed concerns that an earlier deadline would “strain already limited” resources and “unreasonably constrain” the center’s ability to properly address Vanda’s submission requesting summary judgment or a hearing.“CDER is committed to working diligently to comply with our obligations in this matter, including meeting the deadline to be set forth by the commissioner,” Warren concluded. “However, competing agency priorities and judicial developments relating to various lawsuits Vanda has initiated may arise unexpectedly that are outside the control of either the center or the agency as a whole.”Both the FDA and the agency’s parent organization, the Department of Health and Human Services, did not respond to Fierce Biotech’s request for comment.