PRINCETON, N.J., July 28, 2024 – Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s ERZOFRI® (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring relapses1. Antipsychotic medications play an important role in treating and controlling symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dosing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers2.
ERZOFRI, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S. The product was granted a U.S. patent (Patent No.11,666,573) in 2023, which will expire in 2039. ERZOFRI is approved as a new drug under the 505(b) (2) pathway in the U.S.
According to publicly available information, the sales of paliperidone palmitate LAIs were $2.897 billion across the U.S. in 20233. ERZOFRI will provide patients with a new treatment option after its launch.
References：
1. Anne Rivelli, Veronica Fitzpatrick, Michael Nelson, et al. Real-world predictors of relapse in patients with schizophrenia and schizoaffective disorder in a large health system. Schizophrenia (Heidelb) (2024). DOI: 10.1038/s41537-024-00448-2.
2. Carmela Benson, Charmi Patel, Inyoung Lee, et al. Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder. J Manag Care Spec Pharm. 2024 Jun 3:1-13. doi: 10.18553/jmcp.2024.23252.
3. Johnson & Johnson. 2023 Annual Report. Available at: https://s203.q4cdn.com/636242992/files/doc_downloads/Annual_meeting/2024/Johnson-Johnson-2023-Annual-Report.pdf. Accessed on July 15, 2024.
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