J&J Looks To Expand Spravato Label To Suicidal Ideation
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.
You may also be interested in...
The US FDA approved the esketamine nasal spray for adults with major depressive disorder with suicidal ideation or behavior, following its initial approval in 2019 for treatment-resistant depression.
A strong fourth quarter and full-year 2019 performance by J&J was driven by significant sales growth for Tremfya and Stelara. CFO Wolk said a $4bn opioids settlement remains on track.
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.