Vanda Pharma granted favourable Court ruling over FDA’s Hetlioz approvability

Vanda Pharmaceuticals (VNDA) secured a victory over the FDA in its longstanding dispute with the agency regarding the approvability of Hetlioz to treat jet lag disorder. Vanda submitted its supplemental New Drug Application in October 2018 to market Hetlioz 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. The FDA did not commence a hearing. It instead granted summary judgment to itself and issued an order refusing to approve the sNDA. Vanda thus filed a petition for review with the U.S. Court of Appeals for the D.C. Circuit. The Court set aside the FDA’s action. 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.” 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.