Boehringer Ingelheim’s BI 425809 Receives the US FDA’s Breakthrough Therapy Designation for Cognitive Impairment Associated with Schizophrenia
Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases
Shots:
- The BTD is based on P-II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia
- Moreover, the company has initiated the P-III CONNEX program assessing the safety and efficacy of BI 425809 vs PBO for improving cognition in adults with schizophrenia over a 26wks. treatment period
- Additionally, Boehringer Ingelheim will also use VeraSci’s VRFCAT which is an assessment that improves clinical trials by detecting functional improvements in patients’ everyday lives. BI 425809 is a novel glycine transporter-1 (GlyT1) inhibitor
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