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LY03010 (Paliperidone Palmitate Once-Monthly [PP1M])

ERZOFRI®

Small molecule

LY03010 (paliperidone palmitate once-monthly injectable) marketed under the brand name ERZOFRI® is indicated for the treatment of schizophrenia and schizoaffective disorders. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) based on a multicenter, randomized, open-label relative bioavailability study (NCT04922593) which established the bioequivalence of LY03010 and INVEGA SUSTENNA® at steady state and comparatively evaluated the pharmacokinetics of paliperidone during the initial dosing regimen (IDR). Comparable therapeutic levels of paliperidone were observed during the IDRs of both drugs, however, LY03010 is given consistently once a month from initiation, in comparison to two weekly injections for the initiation doses of INVEGA SUSTENNA®.

A New Drug Application (NDA) for LY03010 was submitted to the U.S. FDA via the 505(b)(2) pathway. Following this submission, Luye Pharma Group Ltd. sent a Paragraph IV patent declaration to the Marketing Authorisation Holder and the patent owner of INVEGA SUSTENNA®. LY03010 was granted a patent (Patent No.11,666,573) in the U.S. in 2023, which will expire in 2039. On July 28 2024, the U.S. FDA approved LY03010 under the brand name ERZOFRI® 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 injectable developed in China to be approved in the U.S.

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