FDA Approves Erzofri (Paliperidone Palmitate) for Schizophrenia and Schizoaffective Disorder
核心洞察
The FDA has approved Erzofri (paliperidone palmitate) as a monthly injectable for treating schizophrenia (搜索) and schizoaffective disorder (搜索) in adults.
Erzofri is the first paliperidone palmitate long-acting injection developed in China to receive U.S. approval, offering a new treatment option.
Approval was based on a study demonstrating bioequivalence to Invega Sustenna, with a comparable safety profile and optimized initial dosing.
The U.S. Food and Drug Administration (FDA) has approved Erzofri (paliperidone palmitate) extended-release injectable suspension, developed by Luye Pharma Group (搜索), for the treatment of schizophrenia (搜索) and schizoaffective disorder (搜索) in adults. Erzofri is indicated both as a monotherapy and as an adjunct to mood stabilizers or antidepressants for schizoaffective disorder.
Schizophrenia (搜索) and schizoaffective disorder (搜索) are chronic psychiatric conditions characterized by recurring relapses. Antipsychotic medications are crucial for managing these conditions, but patient adherence is often poor. Long-acting injectable (LAI) antipsychotics like Erzofri improve adherence by reducing dosing frequency, addressing a significant challenge in patient care.
Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the U.S. It received U.S. patent No. 11,666,573 in 2023, which is set to expire in 2039. The drug was approved under the 505(b)(2) regulatory pathway.
Clinical Trial Data
The FDA's approval was based on an open-label, randomized, multiple-dose study (NCT04922593) involving 281 patients aged 18-65 with schizophrenia (搜索) or schizoaffective disorder (搜索). The study evaluated the pharmacokinetic profile of Erzofri and its relative bioavailability compared to Invega Sustenna. Results demonstrated that Erzofri is bioequivalent to Invega Sustenna at steady state after multiple injections. The initial dosing of Erzofri was optimized by omitting the injection on Day 8 after the first injection, resulting in comparable total drug exposure. The safety profile of Erzofri was consistent with that of Invega Sustenna.
Safety Information
Erzofri carries a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis and is contraindicated in patients with known hypersensitivity to paliperidone or risperidone. Common adverse reactions include injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.
Market Context
According to publicly available information, the sales of paliperidone palmitate LAIs were $2.897 billion across the U.S. in 2023. Erzofri will provide patients with a new treatment option after its launch.
Luye Pharma Group (搜索), the manufacturer of Erzofri, is an international pharmaceutical company focused on the R&D, manufacturing, and sales of innovative medications. They have established R&D centers in China, the U.S., and Europe, with a pipeline of over 30 drug candidates in China and more than 10 in other international markets.