Complete Response Letter NDA 505b1 217002 (Feb 26, 2024)
The FDA has identified several deficiencies in the New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia. Key issues include insufficient evidence for efficacy from Study C07, lack of data on co-administration with antipsychotics, unproven clinical meaningfulness of the observed effect on negative symptoms, and inadequate long-term safety data. Additionally, the proposed strategy for mitigating QTc prolongation risk based on CYP2D6 genotyping is deemed insufficient, requiring a robust companion diagnostic device. The FDA requires the submission of additional studies and data to address these deficiencies before the application can be approved.
