FDA Approves Erzofri for the Treatment of Schizophrenia and Schizoaffective Disorder

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The US Food and Drug Administration (FDA) has approved Luye Pharma’s paliperidone palmitate (Erzofri) extended-release injectable suspension for the treatment of schizophrenia in adults and schizoaffective disorder in adults as monotherapy, as well as an adjunct to mood stabilizers or antidepressants.¹

Administered once monthly, Erzofri is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the US. In 2023, the product was granted a US patent (Patent No.11,666,573), and it will expire in 2039. Erzofri is approved as a new drug under the 505(b) (2) pathway. Erzofri is the second long-acting injectable paliperidone palmitate product to receive FDA approval. Janssen's monthly injectable formulation, Invega Sustenna, received approval in 2009, followed by its 3-month formulation (Invega Trinza) and 6-month formulation (Invega Hafyera).

“As a long-acting injection, [Erzofri] can improve the common medication compliance issues associated with oral antipsychotic drugs and patients with schizophrenia. Compared to another similar drug on the market, Invega Sustenna, [Erzofri] optimizes the initial dosing regimen, increasing patient compliance and potentially bringing greater convenience to patients,” Luye Pharma stated previously.²

This approval is based on the results of an open-label, randomized, multiple-dose, parallel-group study that enrolled 281 participants, aged 18 to 65, with schizophrenia or schizoaffective disorder (NCT04922593). The study was designed to evaluate the PK profile of Erzofri and its relative bioavailability compared with. Erzofri was demonstrated to be bioequivalent at steady state after multiple injections. When compared with Invega Sustenna, Erzofri’s initial dosing was optimized by omitting the injection on day 8 after the first injection, resulting in a comparable total drug exposure. Erzofri’s safety profile was consistent with the known safety profile of Invega Sustenna. The most common adverse reactions (incidence greater than or equal to 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.

“The purpose of developing innovative formulations is to address unmet clinical needs, which includes covering aspects such as drug efficacy, compliance issues and side effects, among others. With a focus on patient experience and needs, we are committed to working tirelessly to reduce the burden of disease by bringing differentiated and clinically meaningful innovation to the market,” said Yang Rongbing, president of Luye Pharma Group.²

References

1. Luye Pharma announces U.S. FDA approval of Erzofri® (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder. News release. July 29, 2024. Accessed July 30, 2024. https://www.biospace.com/luye-pharma-announces-u-s-fda-approval-of-erzofri-paliperidone-palmitate-extended-release-injectable-suspension-for-treating-schizophrenia-and-schizoaffective-disorder

2. Luye Pharma’s innovative formulation LY03010 meets endpoints in pivotal U.S. study. News release. November 21, 2022. Accessed July 30, 2024. https://www.luye.cn/lvye_en/view.php?id=2115