In a rare move, the FDA’s Center for Drug Evaluation and Research publicly disclosed more information about why it rejected a new indication for Vanda Pharmaceuticals’ sleep disorder drug.
The company had sought to add insomnia to the label for Hetlioz, which is approved to treat non-24-hour sleep-wake disorder and a rare genetic disorder called Smith-Magenis syndrome. Back in February, Vanda sued the FDA over the delay in its decision. A month later, the FDA rejected Vanda’s label expansion, citing deficiencies with the application.
The FDA said this week that it “cannot approve the application in its current form,” and it is now providing an opportunity for a hearing to Vanda.
Vanda criticized the FDA’s latest action, telling Endpoints News on Thursday that “the FDA’s deadline had long passed” when it filed its lawsuit.
“These routine, egregious delays by the FDA badly disserve the public, disrupting pharmaceutical innovation that seeks to bring life-saving or life-altering new treatments to Americans who should not be forced to wait because of bureaucratic delay,” the company said.
At the same time, Vanda is facing pressure to accept a $466 million offer to be acquired by Cycle Pharmaceuticals. The offer is a 63% premium above Vanda’s closing price on May 23, the day before Cycle made its offer. Vanda’s stock $VNDA was up about 25% on Thursday afternoon after Cycle disclosed the takeover bid.
In its comments, the regulator detailed some of its concerns with Vanda’s application, saying the company “does not provide substantial evidence of effectiveness for tasimelteon and does not demonstrate that the drug is safe for the treatment of insomnia.” It also noted that two of the three studies submitted for review excluded patients with insomnia, and there was no evidence to suggest that data in healthy participants “would correspond to a similar degree of response in patients with insomnia disorder.”
A third study “lacks the features of a study that could alone provide substantial evidence of effectiveness,” the agency said, and confirmatory evidence proposed in the application “would be insufficient.”
The FDA said Vanda would need to submit “at least one positive, adequate, and well-controlled study that addresses the deficiencies described in the complete response letter.”