Luye Pharma Group has announced that the US 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 relapses. 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 providers.

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 US 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 USD 2.897 billion across the US in 2023. ERZOFRI will provide patients with a new treatment option after its launch.