In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
Vanda Pharmaceuticals (Nasdaq: VNDA) has achieved a significant legal victory against the FDA in its pursuit to get HETLIOZ庐 (tasimelteon) approved for treating jet lag disorder. The U.S. Court of Appeals for the D.C. Circuit has overturned the FDA's denial of Vanda's supplemental New Drug Application (sNDA), which was originally submitted in October 2018.
The Court ruled that the FDA failed to properly consider Vanda's evidence, noting that the company provided "specific, reasoned, and rooted in evidence" expert views. Clinical trials demonstrated statistically significant improvement in primary endpoints for treating sleep disturbance. The case has been remanded to the FDA, which must now either approve the sNDA or grant Vanda a hearing.
This landmark decision sets a precedent requiring the FDA to meaningfully engage with evidence presented by drug innovators, potentially transforming the regulatory landscape for pharmaceutical companies.
Vanda Pharmaceuticals (Nasdaq: VNDA) ha ottenuto una significativa vittoria legale contro la FDA nella sua richiesta di approvazione di HETLIOZ庐 (tasimelteon) per il trattamento del disturbo da jet lag. La Corte d'Appello degli Stati Uniti per il Circuito D.C. ha annullato il diniego della FDA alla sNDA presentata da Vanda nell'ottobre 2018.
La Corte ha rilevato che la FDA non ha valutato adeguatamente le prove fornite da Vanda, sottolineando che l'azienda aveva presentato pareri di esperti "specifici, motivati e fondati su evidenze". Gli studi clinici hanno mostrato un miglioramento statisticamente significativo negli endpoint primari relativi al disturbo del sonno. Il caso 猫 stato rinviato alla FDA, che ora deve approvare la sNDA o concedere a Vanda un'audizione.
Questa decisione storica stabilisce un precedente che impone alla FDA di confrontarsi concretamente con le evidenze presentate dagli innovatori farmaceutici, con potenziali effetti sul quadro regolatorio per le aziende del settore.
Vanda Pharmaceuticals (Nasdaq: VNDA) ha conseguido una importante victoria legal contra la FDA en su intento de lograr la aprobaci贸n de HETLIOZ庐 (tasimelteon) para el trastorno por jet lag. El Tribunal de Apelaciones de Estados Unidos para el Circuito D.C. ha revocado la denegaci贸n de la FDA a la sNDA de Vanda presentada en octubre de 2018.
El Tribunal determin贸 que la FDA no consider贸 debidamente las pruebas aportadas por Vanda, se帽alando que la compa帽铆a present贸 opiniones de expertos "espec铆ficas, fundamentadas y basadas en evidencias". Los ensayos cl铆nicos mostraron una mejora estad铆sticamente significativa en los endpoints primarios relacionados con las alteraciones del sue帽o. El caso ha sido remitido a la FDA, que ahora debe aprobar la sNDA o conceder a Vanda una audiencia.
Esta decisi贸n hist贸rica sienta un precedente que obliga a la FDA a involucrarse de manera significativa con la evidencia presentada por los innovadores farmac茅uticos, lo que podr铆a transformar el panorama regulatorio para las empresas del sector.
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Vanda Pharmaceuticals (Nasdaq: VNDA) a obtenu une victoire juridique majeure contre la FDA dans sa d茅marche d'approbation de HETLIOZ庐 (tasimelteon) pour le trouble du d茅calage horaire. La Cour d'appel des 脡tats-Unis pour le circuit du D.C. a annul茅 le refus de la FDA concernant la sNDA soumise par Vanda en octobre 2018.
La Cour a estim茅 que la FDA n'avait pas correctement pris en compte les 茅l茅ments de preuve fournis par Vanda, notant que la soci茅t茅 avait pr茅sent茅 des avis d'experts 芦聽pr茅cis, motiv茅s et fond茅s sur des preuves聽禄. Les essais cliniques ont montr茅 une am茅lioration statistiquement significative des crit猫res principaux pour le traitement des troubles du sommeil. L'affaire a 茅t茅 renvoy茅e 脿 la FDA, qui doit d茅sormais soit approuver la sNDA, soit accorder 脿 Vanda une audience.
Cette d茅cision historique cr茅e un pr茅c茅dent exigeant que la FDA engage un examen substantiel des preuves pr茅sent茅es par les innovateurs pharmaceutiques, ce qui pourrait transformer le paysage r茅glementaire du secteur.
Vanda Pharmaceuticals (Nasdaq: VNDA) hat einen bedeutenden rechtlichen Erfolg gegen die FDA erzielt, als Teil des Versuchs, HETLIOZ庐 (tasimelteon) zur Behandlung von Jetlag zuzulassen. Das US-Berufungsgericht f眉r den D.C. Circuit hat die Ablehnung von Vandas erg盲nzender Zulassungsanmeldung (sNDA) aufgehoben, die urspr眉nglich im Oktober 2018 eingereicht wurde.
Das Gericht befand, dass die FDA Vandas Beweise nicht angemessen ber眉cksichtigt habe und stellte fest, dass das Unternehmen fachliche Bewertungen vorgelegt habe, die "spezifisch, begr眉ndet und evidenzbasiert" seien. Klinische Studien zeigten eine statistisch signifikante Verbesserung der prim盲ren Endpunkte bei der Behandlung von Schlafst枚rungen. Der Fall wurde an die FDA zur眉ckverwiesen, die nun entweder die sNDA genehmigen oder Vanda eine Anh枚rung gew盲hren muss.
Diese bahnbrechende Entscheidung setzt einen Pr盲zedenzfall, der die FDA dazu verpflichtet, sich inhaltlich mit den von Arzneimittelentwicklern vorgelegten Beweisen auseinanderzusetzen und damit die regulatorische Landschaft f眉r Pharmaunternehmen ver盲ndern k枚nnte.
- Court victory overturns FDA's denial of HETLIOZ for jet lag disorder treatment
- Clinical trials showed statistically significant improvement in primary endpoints
- Landmark legal precedent requiring FDA to properly evaluate scientific evidence
- Potential expansion of HETLIOZ into new therapeutic indication
- Extended regulatory delay since original 2018 sNDA submission
- Still requires final FDA approval or hearing process
- Previous FDA resistance to approving the application despite evidence
Insights
Vanda wins critical appeals court victory that could lead to HETLIOZ approval for jet lag, challenging FDA's regulatory approach.
This federal appeals court ruling represents a significant regulatory victory for Vanda Pharmaceuticals in its long-running battle with the FDA over HETLIOZ庐 (tasimelteon) for jet lag disorder. The court's decision to overturn the FDA's denial is particularly notable for criticizing the agency's failure to meaningfully engage with Vanda's clinical evidence. The court specifically noted that Vanda provided "specific, reasoned, and rooted in evidence" expert views that the FDA treated in a "cursory" manner, despite trials showing "statistically significant improvement on the primary endpoint measured."
The ruling carries broader regulatory implications by potentially shifting the power dynamic between drug developers and the FDA. It establishes a precedent requiring the agency to more thoroughly address scientific evidence presented by pharmaceutical companies rather than dismissing it without substantive engagement. This could benefit other drug developers facing similar regulatory hurdles.
For Vanda specifically, this decision reopens the pathway for HETLIOZ庐 approval for jet lag disorder, a condition affecting travelers crossing multiple time zones. The company originally submitted its supplemental New Drug Application in
The court has remanded the case to the FDA, where the agency must now either approve the application or grant Vanda the hearing it has long sought. This represents a rare instance of successful judicial challenge to FDA decision-making authority and may encourage other companies to more aggressively pursue legal remedies when they believe the agency has acted improperly in evaluating their applications.
Vanda submitted its supplemental New Drug Application (sNDA) in October 2018 to market HETLIOZ庐 to treat jet lag disorder. After the FDA substantially delayed resolving Vanda's request for a hearing with respect to this application, a federal district court found that the FDA "violated" the requirements of the Food, Drug, and Cosmetic Act, and the court ordered the FDA to finally resolve Vanda's sNDA or commence a hearing (Vanda Pharmaceuticals Inc. v. FDA, No. 22-cv-2775-CJN).
The FDA did not commence a hearing. It instead granted summary judgment to itself and issued an order refusing to approve the sNDA. The FDA took the position that it could essentially disregard the voluminous factual evidence Vanda had presented to it. Vanda thus filed a petition for review with the
In a sweeping win for Vanda, the Court set aside the FDA's action. The Court explained that Vanda provided expert views that were "specific, reasoned, and rooted in evidence" and that the FDA's "treatment of Vanda's evidence is cursory." In particular, the Court stated that Vanda "clearly offered meaningful evidence of tasimelteon's efficacy in improving sleep disturbance" and, further, that each of its trials "showed statistically significant improvement on the primary endpoint measured."
This decision significantly alters the relationship between the FDA and the parties it regulates. The Court's holding establishes that the FDA must meaningfully engage with the evidence presented by drug innovators, and the FDA may not shield its decisions via a plea for deference. The Court has remanded the case back to the FDA, where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing.聽
This is an outstanding development for all those who suffer from jet lag. Vanda has spent more than a decade undertaking innovative clinical studies, now published in peer-reviewed journals, developing HETLIOZ庐 so that jet lag sufferers may finally have access to a meaningful therapeutic.1 2 3 4 Whether for an athlete, a business traveler, a government official, a tourist, or rapidly deployed troops, HETLIOZ庐 has the potential to fundamentally change the landscape of circadian resetting during transmeridian global travel. This is a treatment that Americans want and need.
Ultimately, this decision requires that the FDA act fairly when evaluating scientific evidence. The FDA's decisions regarding new drug applications are enormously consequential. Innovators like Vanda labor to bring novel therapeutics to Americans who suffer from unmet medical needs. Improper denials by the FDA deprive the public of access to potentially life-changing medication. The Court's decision establishes that the FDA must now actually engage with the evidence presented to it.
The Court's decision confirms Vanda's efforts to challenge unlawful actions by the FDA. For too long, drug manufacturers failed to exercise their rights to lawful treatment by the FDA. Vanda has demonstrated how courts can set aside illegal government actions that harm innovation and deprive Americans of important new therapeutics.
Vanda looks forward to further demonstrating that HETLIOZ庐 should be approved to treat jet lag disorder.
References
- Rajaratnam, S., Polymeropoulos, M., Fisher, D., Roth, T., Scott, C., Birznieks, G., Klerman, E. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet 2009; 373(9662):482-91. See also Cardinali, D., Golombek, D. Let there be sleep鈥攐n time. Ibid. 439-41.听
- Polymeropoulos, C., Mohrman, M., Keefe, M., Brzezynski, J., Wang, J., Prokosch, L., Polymeropoulos, V., Xiao, C., Birznieks, G., Polymeropoulos, M. Efficacy of Tasimelteon (HETLIOZ庐) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020; 11:611.
- Polymeropoulos, C., Polymeropoulos V., Cziesler, E., Fisher, M., Smieszek, S., Xiao, C., Birznieks, G., Polymeropoulos, M. Once-daily tasimelteon (VEC-162) for jet lag following transmeridian travel: A multicenter, randomized, double-blind, placebo-controlled trial. Front Neurol. 2022; 13:901467.
- See also聽Arendt, J. Approaches to the Pharmacological Management of Jet Lag. Drugs 2018;78(14):1419鈥�1431.
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 聽and follow us on X @vandapharma.
About HETLIOZ庐
For full
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS聽
Various statements in this press release, including, but not limited to statements regarding Vanda's prospects for receiving approval of HETLIOZ庐 or a hearing following the FDA's further review of the sNDA following remand, the potential of HETLIOZ庐 to address the needs of travelers suffering from jet lag disorder and the anticipated future behavior of the judiciary, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the outcome of the FDA's further review of the sNDA, the ability of HETLIOZ庐 to fundamentally change the landscape of circadian resetting during transmeridian global travel, and the willingness of other courts to set aside the actions of the FDA. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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