Vanda Pharmaceuticals Secures FDA Approval for Jet Lag Treatment After Appeals Court Overturns Denial

Vanda Pharmaceuticals has won an appeal against the FDA's decision to deny approval for its jet lag drug. The appeals court has overturned the FDA's order, allowing Vanda to proceed with the drug's development. This decision is a significant milestone for Vanda, which has been focused on developing treatments for high unmet medical needs.

Vanda Pharmaceuticals Inc. (Vanda) has secured a significant victory in its ongoing dispute with the U.S. Food and Drug Administration (FDA) over the approval of HETLIOZ® (tasimelteon) for the treatment of jet lag disorder. The U.S. Court of Appeals for the D.C. Circuit has overturned the FDA's decision to deny approval of the drug, paving the way for Vanda to proceed with its development.

The appeal, Vanda Pharmaceuticals Inc. v. FDA (case no. 24-1049), stems from Vanda's supplemental New Drug Application (sNDA) submitted in October 2018. The FDA had substantially delayed resolving Vanda's request for a hearing regarding the sNDA, leading to a federal district court ordering the FDA to either resolve the application or commence a hearing. The FDA, however, chose to grant itself summary judgment and refused to approve the sNDA, arguing it could disregard the extensive evidence presented by Vanda.

The appeals court, in a sweeping decision, set aside the FDA's order. The court noted that Vanda's evidence was "specific, reasoned, and rooted in evidence," and that the FDA's treatment of this evidence was cursory. The court emphasized that Vanda provided meaningful evidence of tasimelteon's efficacy in improving sleep disturbance, with trials showing statistically significant improvements on primary endpoints [1].

This decision marks a significant shift in the relationship between the FDA and the drug innovators it regulates. The court has established that the FDA must engage meaningfully with the evidence presented by drug companies and cannot shield its decisions via deference. The case has been remanded back to the FDA, where Vanda anticipates either approval of the sNDA or a hearing [2].

The approval of HETLIOZ® could have a substantial impact on the treatment of jet lag disorder, which affects a wide range of individuals, including athletes, business travelers, and government officials. Vanda has been conducting innovative clinical studies on the drug for over a decade, with trials published in peer-reviewed journals [3, 4, 5].

This development underscores the importance of fair evaluation of scientific evidence in FDA decisions, which can have enormous consequences for public health. The court's decision reaffirms that the FDA must engage with the evidence presented to it, ensuring that potentially life-changing medications are not improperly denied [1].

References:
[1] https://www.prnewswire.com/news-releases/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fdas-order-denying-approval-of-hetlioz-for-the-treatment-of-jet-lag-disorder-302531842.html
[2] https://www.marketscreener.com/news/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fda-s-order-denying-approval-of-hetlioz-ce7c51dfd181ff20
[3] 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.
[4] Polymeropoulos, C., Mohrman, M., Keefe, M., Brzezynski, J., Wang, J., Prokosch, L., Polymeropoulos, V., Xiao, C., Birznieks, G., Polymeropoulos, M. Efficacy of Tasimelteon (HETLIOZ®) 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.
[5] 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.