J&J's Spravato Set For EU Launches Soon
Ketamine-Like Antidepressant Backed By CHMP
If the nasal spray is approved by the European Commission, seven months after getting the green light in the US, Spravato will offer the ﬁrst new mechanism of action in 30 years to treat major depressive disorder.
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Uncertainties over clinical and cost effectiveness are behind the health technology assessment body’s recommendation against Spravato's use on the National Health Service.
Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.
The big pharma will seek the new indication later this year based on Phase III data showing a rapid decrease in depression symptoms, but without a significant improvement over placebo in suicidality.