China-based Luye Pharma Group (HKG: 2186) has announced receiving market approval from the US Food and Drug Administration (FDA) for its extended-release injectable suspension Rykindo (risperidone). The drug is approved for the treatment of schizophrenia in adults and as a monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Rykindo’s Technology and Clinical Profile
Rykindo, developed by Luye Pharma on its microsphere technology platform, is administered via intramuscular injection once every two weeks. The drug delivers the active ingredient, risperidone, through long-acting and extended-release microsphere technology. This formulation enhances patient compliance by reducing the frequency of dosing compared to traditional oral formulations. Rykindo was initially approved for marketing in China in 2021 for the treatment of schizophrenia, highlighting its growing clinical acceptance.
Global Development and Market Expansion
The approval by the US FDA marks a significant milestone for Luye Pharma as it seeks to expand the global footprint of Rykindo. The company is also progressing with the development of Rykindo in Europe and plans to launch the drug in additional countries and regions worldwide. This strategic approach underscores Luye Pharma’s commitment to making Rykindo available to patients globally, addressing significant unmet needs in the treatment of schizophrenia and bipolar I disorder.
Future Outlook
Luye Pharma’s receipt of FDA approval for Rykindo highlights the company’s innovation capabilities and its dedication to advancing treatments for central nervous system disorders. With its extended-release formulation and broad therapeutic applications, Rykindo is poised to make a meaningful impact on patient outcomes. The company’s ongoing efforts to expand the drug’s availability globally further solidify its position in the pharmaceutical industry.-Fineline Info & Tech
