FDA staff issue positive review of Vanda's tasimelteon; shares jump

Vanda Pharmaceuticals' shares surged as much as 88 percent Tuesday after FDA reviewers said that the company's drug tasimelteon is safe and effective enough to warrant approval to treat non-24-hour disorder. In documents posted ahead of an advisory committee meeting on November 14, agency staff noted that the medicine, which targets the hormone melatonin, is effective at synchronising the body with a 24-hour cycle.

"The efficacy for tasimelteon in the treatment of non-24 hour disorder has been demonstrated on clinical outcomes in two clinical studies," said FDA reviewer Devanand Jillapalli, adding that no major safety issues were observed. Vanda noted that in the trials, the drug offered improvements to patients across a variety of sleep-and-wake measures, including total sleep time, daytime nap duration and overall functioning. Commenting on the review, JMP Securities analyst Jason Butler said it allayed many investor fears on how the advisory meeting may go, adding it was rare for an FDA reviewer to recommend drug approval in a briefing document.

The FDA is expected to decide whether to approve tasimelteon, which Vanda has proposed calling Hetlioz, by January 31, after granting the company's filing priority review in July. Vanda noted that no approved treatments currently exist for non-24-hour disorder, which affects as many as 95 000 totally blind people in the US.

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