German family-owned pharma major Boehringer Ingelheim recently announced that its product, BI 425809, has received Breakthrough Therapy designation (BTD) by the US Food and Drug Administration for cognitive impairment associated with schizophrenia (CIAS).
There are currently no approved pharmacological treatments for CIAS and if BI 425809 is successful, it could address this unmet need in the schizophrenia market. It is anticipated that BI 425809 will be launched in 2026 in the US, says data and analytics company GlobalData.
Christie Wong, pharma analyst at GlobalData, comments: “The current schizophrenia treatment landscape includes a high number of established atypical antipsychotic products that can effectively manage the positive symptoms of the disorder; however, there is a significant unmet need for novel effective treatment options for the negative symptoms and cognitive impairments seen in schizophrenia.”
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