FDA approves Luye Pharma’s ERZOFRI for schizophrenia

The US Food and Drug Administration (FDA) has approved Luye Pharma’s ERZOFRI (paliperidone palmitate) extended-release injectable suspension for the treatment of schizophrenia in adults.

The approval also extends to the treatment of schizoaffective disorder in adults, either as a standalone therapy or in conjunction with mood stabilisers or antidepressants.

Schizophrenia and schizoaffective disorder are severe, chronic psychiatric conditions that often result in relapses. Antipsychotic medications are crucial in managing and alleviating the symptoms associated with the disorders, but adherence to treatment regimens is typically low.

Long-acting injectable (LAI) antipsychotics, such as ERZOFRI, have been shown to enhance patient adherence.

Administered monthly, ERZOFRI reduces the need for frequent dosing and minimises the risk of patients deviating from their prescribed treatment without their healthcare provider’s knowledge. ERZOFRI is the first patented long-acting injection of paliperidone palmitate developed in China to receive approval in the US.

The product, patented in 2023 (Patent No. 11,666,573), is protected until 2039. It received approval as a new drug under the 505(b)(2) pathway in the US. Last year, sales of paliperidone palmitate LAIs reached $2.897bn in the US market.

 

August 1, 2024