Vanda wins appeals court fight over FDA jet lag ruling

Vanda Pharmaceuticals (Nasdaq: VNDA) secured a sweeping victory in its legal battle with the US regulator after the Court of Appeals for the District of Columbia Circuit overturned the agency’s refusal to approve Hetlioz (tasimelteon) for jet lag disorder. The ruling set aside the Food and Drug Administration's (FDA) prior rejection.

The appeals court concluded that Vanda’s evidence was “specific, reasoned, and rooted in evidence” and that the FDA’s treatment of the data was “cursory.” The case has now been sent back to the regulator, which must either approve Hetlioz for jet lag or grant the company a hearing.

“This decision significantly alters the relationship between the FDA and the parties it regulates,” Vanda said. “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.”