FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder

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The FDA has approved Luye Pharma Group’s Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. According to the company, the treatment is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the United States. The product was granted a US patent in 2023, set to expire in 2039, and was approved as a new drug under the 505(b)(2) pathway.1 The approval is based on results from the company’s pivotal United States study of Erzofri.¹

“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. We are rapidly advancing with the development of LY03010 and hope to provide a new treatment option to patients as quickly as we can,” said Yang Rongbing, president, Luye Pharma Group, in a press release regarding a successful clinical trial of Erzofri.

The pivotal, randomized, multiple-dose, open-label, parallel-group study compared the pharmacokinetic profiles of Erzofr (LY03010) and the relative steady state bioavailability of Erzofri versus Invega Sustenna in patients with schizophrenia or schizoaffective disorder. During the study, 281 patients were randomly assigned in a 1:1 ratio to receive either Erzofri or Invega Sustenna.

The results found that with an optimized initial dosing regimen, Erzofri demonstrated a steady state of bioequivalence compared to Invega Sustenna. Additionally, the results found that after injection, preferred exposure levels were achieved within one week, which was considered to be comparable to Invega Sustenna. Common adverse events (AEs) included injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. However, the treatment was well tolerated, with no unexpected treatment-emergent AEs compared to Invega Sustenna.²

According to the World Health Organization (WHO), schizophrenia affects approximately 24 million people globally, including one in every 222 adults, making it less common than other mental disorders. In most cases, schizophrenia begins to manifest during late adolescence and the twenties, with early onset being more in common in men as opposed to women. It is suggested that people struggling with schizophrenia are two to three times more likely to die earlier in life than the general population due to physical illnesses, such as cardiovascular, metabolic, and infectious diseases.

Despite the awareness around schizophrenia, WHO suggests that the majority of those diagnosed with it are not receiving the appropriate mental health care. WHO also estimates that nearly half of patients who reside in mental health hospitals have schizophrenia, while only 31.5% of people with psychosis receive specialist mental health care.³

“There is clear evidence that mental hospitals are not effective in providing the care that people with mental health conditions need and, regularly, violate the basic human rights of persons with schizophrenia. Efforts to transfer care from mental health institutions to the community need to be expanded and accelerated. Such efforts start with the development of a range of quality community-based mental health services,” reports WHO. “Options for community-based mental health care include integration in primary health and general hospital care, community mental health centers, day centers, supported housing, and outreach services for home-based support. The engagement of the person with schizophrenia, family members and the wider community in providing support is important.”

At launch, Luve Pharma expects Erzofri to provide patients with a new treatment option, citing that paliperidone palmitate long-acting injectables profited $2.897 billion in the United States last year.¹

References

1. Luye Pharma Announces U.S. FDA Approval of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for Treating Schizophrenia and Schizoaffective Disorder. PR Newswire. July 28, 2024. Accessed July 30, 2024. https://www.prnewswire.com/news-releases/luye-pharma-announces-us-fda-approval-of-erzofri-paliperidone-palmitate-extended-release-injectable-suspension-for-treating-schizophrenia-and-schizoaffective-disorder-302208155.html

2. Luye Pharma’s Innovative Formulation LY03010 Meets Endpoints in Pivotal U.S. Study. Luye. November 21, 2022. Accessed July 30, 2024. https://www.luye.cn/lvye_en/view.php?id=2115

3. Schizophrenia. WHO. January 10, 2022. Accessed July 30, 2024. https://www.who.int/news-room/fact-sheets/detail/schizophrenia