Tradipitant

The Vanda CEO acknowledges that Califf may be leaving the FDA soon under the new administration, but he still hopes that the commissioner will consider his thoughts.\n After Vanda Pharmaceuticals’ phase 3 miss and FDA rejection for its stomach disorder candidate, CEO Mihael Polymeropoulos, M.D., is calling out the regulatory agency for a “disturbing pattern of conduct” that “harms the American public.”In a searing letter penned to current FDA Commissioner Robert Califf, M.D., Polymeropoulos addresses the rejection Vanda received in September 2024, deeming the agency’s review process as “faulty,” according to the Jan. 8 letter (PDF).The biotech had requested approval for its NK-1R antagonist tradipitant in gastroparesis, with Polymeropoulos claiming at the time that the complete response letter (CRL) generally disregarded the evidence.In a late-stage study (PDF), tradipitant was 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 said the study hit its primary endpoint.Now, the CEO is accusing the FDA of skirting public scrutiny for its decisions, something he says could threaten both public health and the agency’s credibility.“In an interview last year you stated that you would not overrule decisions made by civil servants at the agency except in certain cases of ‘corruption’ or ‘temporary insanity’ of the decision maker,” Polymeropoulos wrote, referring to April 2023 MedPage interview with Califf. “Neither the public nor regulated entities like Vanda are able to determine what instances of ‘corruption’ or ‘temporary insanity’ would in your view merit overruling lower-level FDA employee decisions. This opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA.” Last fall, after Vanda received the CRL, Polymeropoulos said he wrote a letter to the FDA’s director of immunology and inflammation Nikolay Nikolov, M.D., regarding the agency’s alleged “sheer disregard for the facts, evidence, and basic scientific principles.” Now, the Vanda CEO claims that Nikolov hasn’t yet acknowledged or responded to his letter.The CEO writes that the lack of response is “unacceptable” and “stems from the seriously misguided nature of your position that you will not overrule decisions made by civil servants at the agency except in extreme situations such as ‘corruption’ or ‘temporary insanity’ of the decision maker,” according to the Jan. 8 release.Polymeropoulos also takes issue with certain advisory committee practices, writing that the FDA denied Vanda’s request to hold an adcomm for tradipitant, a process in which experts and members of the public can share their thoughts on new drug applications. At the end of the letter, the CEO acknowledges that Califf may be leaving the FDA soon under the upcoming Trump administration, but he still hopes that the commissioner will consider his thoughts. Polymeropoulos’ criticism of the FDA is not new: he previously voiced frustrations with the approval process in the run-up to the PDUFA date. In 2020, the biotech took the agency to court over a partial clinical hold for a tradipitant trial, a suit that ultimately landed in favor of the FDA.Vanda’ has been working to snag a tradipitant approval for years after licensing the molecule from Eli Lilly in 2012 and attempting to establish the molecule in eczema—efforts that ended up falling short.In May 2024, the biotech said it planned on filing for approval in the prevention of vomiting in motion sickness by the end of the year.

WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As previously reported, Vanda has sought approval from the U.S. Food and Drug Administration (FDA) for tradipitant for the treatment of patients with gastroparesis. FDA declined to approve Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis, providing Vanda with a Complete Response Letter (CRL) on September 18, 2024. Today, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's NDA for tradipitant for the treatment of gastroparesis. The full letter is shown below: _____________________________________________________________________ Dear Dr. Califf: We are writing to bring your attention to a disturbing pattern of conduct at FDA that impairs the credibility of the agency and harms the American public. In an interview last year you stated that you would not overrule decisions made by civil servants at the Agency except in certain cases of "corruption" or "temporary insanity" of the decision maker.1 Neither the public nor regulated entities like Vanda are able to determine what instances of "corruption" or "temporary insanity" would in your view merit overruling lower-level FDA employee decisions. This opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA. And your agency's review of our application to market tradipitant is no exception. Three months ago, Vanda received a complete response letter (CRL), dated September 18, 2024, in response to the new drug application (NDA) Vanda submitted on September 18, 2023, for the use of tradipitant for the treatment of symptoms of gastroparesis, a serious and debilitating gastrointestinal disorder. We wrote to Dr. Nikolov expressing our surprise "by the sheer disregard for the facts, evidence, and basic scientific principles contained in the complete response"—a letter that could not "possibly reflect a legitimate regulatory review" as it did not "provide reasoned explanations or engage with the evidence we presented on its merit—including voluminous evidence from experts." Three months later, Dr. Nikolov has not even acknowledged that letter, let alone provided a response. This is unacceptable, and stems from the seriously misguided nature of your position that you will not overrule decisions made by civil servants at the Agency except in extreme situations such as "corruption" or "temporary insanity" of the decision maker. As a political appointee and head of the agency, you are the only person accountable to the American public—a public that needs to know that the agency will follow the law and ensure courteous and civil behavior by agency employees. In addition, FDA has denied our request to convene an Advisory Committee to consider our application for tradipitant, a process by which experts and the public can voice their opinion on our application. As you are no doubt aware, the number of Advisory Committee meetings convened by the agency has drastically declined over the last few years. See Cheri Banks, The Future of Voting for FDA Advisory Committees, Federation of American Scientists (Sept. 9, 2024), perma.cc/L8R3-2FJD (noting that in 2021, 6% of drug applications were referred to advisory committees, down from 55% in 2010). You have stated separately that there should be "less voting" by advisory committees, and that you don't believe in "gladiator votes" because "votes don't matter." These statements compound a sentiment that the agency avoids public scrutiny of its decisions, which is dangerous both for public health and agency credibility. I understand that you may be leaving the agency in the new administration, but I hope that you will consider this letter, and I would welcome your thoughts in response. FDA's policies, practices, and culture must be evaluated and corrected so as to align with scientific evidence and the law. Sincerely, Mihael H. Polymeropoulos, M.D. Chief Executive Officer Vanda Pharmaceuticals Inc. 1. MedPage Today, Politics and Controversy in the FDA, YouTube (Apr. 11, 2023) (statement of Commissioner Robert Califf, M.D.), available at . ______________________________________________________________________ The text of the letter to Dr. Nikolov, referenced in the second paragraph of the letter above, is available at: About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED