FDA approves Erzofri (paliperidone palmitate) for the treatment of schizophrenia and schizoaffective disorder
The 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
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.
“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.
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