Vanda’s Hetlioz Marketing: Disease Awareness DTC, Reps For Specialty Docs
This article was originally published in The Pink Sheet Daily
Firm hopes strategy will educate patients about largely unknown condition, non-24 hour sleep-wake disorder, while using small sales force to target sleep experts.
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A Nov. 14 advisory committee gave near-unanimous support for Vanda’s sleep disorder drug on questions about its indication, endpoints, efficacy and safety.
Vanda anticipates that if approved, its drug for the rare “non-24-hour” circadian rhythm disorder will command pricing in line with orphan disease treatments. Second Phase III trial has it on track for a mid-2013 submission.
The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval.