Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review

Rhea-AI Summary

Vanda Pharmaceuticals (NASDAQ: VNDA) has issued a letter to FDA Commissioner Robert M. Califf addressing concerns over the agency's rejection of its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis symptoms. The letter follows a Complete Response Letter (CRL) received on September 18, 2024, which denied approval for the drug.

The company criticizes the FDA's review process, highlighting several issues including: the lack of response from Dr. Nikolov to their concerns about the CRL, the denial of their request for an Advisory Committee meeting, and what they describe as a 'disturbing pattern of conduct' at the FDA. The letter points out a significant decline in Advisory Committee meetings, from 55% of drug applications in 2010 to 6% in 2021.

Vanda argues that the FDA's current policies and practices need realignment with scientific evidence and law, particularly questioning the Commissioner's stance on only overruling civil servants' decisions in cases of 'corruption' or 'temporary insanity.'

Positive

• None.

Negative

• FDA rejected Vanda's NDA for tradipitant in gastroparesis treatment
• FDA denied company's request for Advisory Committee meeting
• No response received from FDA regarding concerns about the Complete Response Letter
• Regulatory setback delays potential market entry for tradipitant

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Data tracked by StockTitan Argus on the day of publication.

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 https://www.youtube.com/watch?reload=9&app=desktop&v=zGrnzM51Jrs.

______________________________________________________________________

The text of the letter to Dr. Nikolov, referenced in the second paragraph of the letter above, is available at: https://assets.vandapharma.com/pdfs/vanda-letter-to-dr-nikolov.pdf

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 www.vandapharma.com and follow us on X @vandapharma.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

Why did the FDA reject Vanda's (VNDA) tradipitant NDA for gastroparesis in September 2024?

The specific reasons for rejection are not detailed in the press release. Vanda indicates the CRL showed 'disregard for facts, evidence, and basic scientific principles' but doesn't provide specific regulatory concerns cited by the FDA.

What is the significance of FDA denying VNDA's Advisory Committee meeting request for tradipitant?

The denial prevents public and expert discussion of the application, limiting transparency in the review process. This follows a trend of declining Advisory Committee meetings, from 55% of drug applications in 2010 to 6% in 2021.

What are the next steps for Vanda (VNDA) following the tradipitant CRL?

The press release doesn't specify next steps, but typically companies can either appeal the decision, request a meeting with the FDA, or conduct additional studies to address the FDA's concerns.

How long has VNDA's tradipitant been under FDA review for gastroparesis?

The NDA was submitted on September 18, 2023, and received a Complete Response Letter (rejection) exactly one year later on September 18, 2024.