Shots:
- The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies
- The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety & tolerability of Cobenfy for over 1yr.
- Studies reached the 1EPs, showing reduced schizophrenia symptoms with 9.6 (-21.2 vs -11.6 in EMERGENT-2) and 8.4 (-20.6 vs -12.2 in EMERGENT-3) point reductions in PANSS total scores at wk.5. EMERGENT-2 study also depicted a change of 0.6 (-1.2 vs -0.7) in CGI-S score at wk.5 (2EP)
Ref: BMS | Image: BMS| Press Release
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