Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and schizophrenic affective disorder, offering it as an option for use as a monotherapy or in conjunction with other antidepressants.
Erzofri represents a long-acting, once-monthly injectable formulation of paliperidone palmitate, designed to enhance patient compliance and simplify medication management through a streamlined initial treatment protocol. The drug’s approval follows positive results from a pivotal US study demonstrating its efficacy and safety profile. In 2023, Erzofri was awarded a US invention patent (US Patent No. 11666573), providing intellectual property protection until 2039.- Flcube.com
