No aid for sleepless in Paris
This article was originally published in Pharmaceutical Approvals Monthly
Sanofi-Aventis received an FDA "complete response" letter for its novel insomnia candidate eplivanserin, the firm announced Sept. 16. The firm said only that FDA is asking for additional information regarding the benefit-risk profile of the serotonin type 2A receptor antagonist. Sanofi is seeking approval to treat patients with chronic insomnia characterized by difficulties with sleep maintenance, a unique claim that could help distinguish a new entrant in a crowded market. The setback is especially critical because the firm faces generic competition for its big money maker in the insomnia market, Ambien, which went off patent in 2007 and saw the launch of its first branded competitor Edular earlier in September by Meda Pharmaceuticals (2"The Pink Sheet" DAILY, Sept. 9, 2009). Sanofi previously had a back-up compound in development - volinanserin - but terminated clinical trials after the compound failed to show efficacy in primary insomnia with predominant sleep maintenance problems
You may also be interested in...
Lozenge form of zolpidem tartrate is the first of several new versions of Ambien that could launch in the coming months.
Device Week, 05 March - Remote Monitoring Reimbursement, T-cell Diagnostics And A Digital Health Feature
In this week's podcast, managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.
Coronavirus Notebook: Italy Makes First Use Of EU’s Vaccine Export Control System, More Regulators Issue Guidance On Variants
Ukraine has established a system for issuing emergency use authorizations for COVID-19 vaccines that recognizes authorizations granted by other world regulators.