China-based Luye Pharma Group announced that the U.S. FDA has approved its antipsychotic — the first innovative therapy from the company's central nervous system product portfolio to get the nod on the U.S. market.
The FDA approved Rykindo (risperidone), an extended-release injectable, for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Rykindo was developed by Luye Pharma on the company's microsphere technology platform. The drug is administered via intramuscular injection once every two weeks and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology.
The therapy was approved for marketing in China in 2021 for the treatment of schizophrenia. The company continues to develop Rykindo in Europe, with plans to launch the drug in more countries and regions around the world.