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July 29, 2024July 28, 2024 - Luye Pharma Group 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.
- Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S.
- Antipsychotic medications are used to treat and control symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. The use of long- acting injectable (LAI) antipsychotics is effective in improving patient adherence.
- Erzofri is not approved for use in patients with dementia-related psychosis, and the safety and effectiveness of Erzofri in pediatric patients have not been established.
Source: Luye Pharma Group