In its fourth-quarter and full-year report for 2023, Vanda Pharmaceuticals Inc highlighted updates on regulatory efforts for Hetlioz (tasimelteon), focusing on expanding its indications to include the treatment of insomnia and jet lag disorder. 

The supplemental new drug application (sNDA) for Hetlioz in the treatment of insomnia is under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act target action date of March 4. 

Vanda announced that on Feb 4 it received a notification from the FDA stating that the FDA had identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. 

On Feb 6, Vanda filed suit in the US District Court for the District of Columbia challenging the FDA’s conduct in reviewing the insomnia sNDA. Vanda is asking the DC District Court to compel the FDA to adhere to the legally mandated 180-day review period for sNDAs and to declare as unlawful and void the regulations the FDA relies upon to issue complete response letters.

Vanda is also continuing to pursue FDA approval for Hetlioz in the treatment of jet lag disorder. Vanda announced in January that the DC District Court granted Vanda’s motion for summary judgment on its claim against the FDA for unlawfully delaying a hearing on the approvability of Vanda’s sNDA for Hetlioz in the treatment of jet lag disorder. The DC District Court ordered the FDA to either finally resolve Vanda’s jet lag sNDA or commence a hearing on the sNDA on or before March 5.

In January, Vanda filed a petition for a writ of certiorari with the US Supreme Court to review the decision of the US Court of Appeals for the Federal Circuit in Vanda’s Hetlioz Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA Inc, Apotex Inc, and Apotex Corp. Teva and Apotex have waived their opportunity to respond to Vanda’s petition, which is now ripe for decision by the US Supreme Court.

Additionally, Vanda announced in January that the United States Court of Federal Claims denied in part the US government’s motion to dismiss Vanda’s claims against the US for the FDA’s uncompensated taking of Vanda’s trade secrets and confidential information, thereby allowing Vanda’s lawsuit to proceed. 

Vanda is seeking compensation from the US for the takings it contends occurred through the FDA’s improper communication and disclosure of trade secrets and confidential information to certain generic drug manufacturers. Vanda now intends to engage in discovery to support its claims.

Photo 25048346 © Ginasanders |