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Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL

 
• By Joseph Haas

Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.

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Vanda's hopes of adding jet lag disorder to Hetlioz's label are at best delayed

The US Food and Drug Administration’s complete response letter for Vanda Pharmaceuticals Inc.’s Hetlioz in jet lag disorder was expected by nearly everyone except the company itself, which said on 19 August that it is “perplexed” by the agency’s assertion that the clinical data backing the sNDA are of “unclear clinical significance.”

The Washington, DC-based firm said it received the CRL on 16 August, which had been the action date for the supplemental new drug application (sNDA). This followed a “Deficiencies Preclude Discussion” letter from the FDA on 19 July telling Vanda the agency was not ready to discuss labeling and post-marketing requirements for Hetlioz in the jet lag disorder (JLD) indication

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