Rykindo, which is a bi-weekly long-acting risperidone injection, is the first therapy from Luye Pharma's CNS product portfolio to be sold in the US
Luye Pharma Group has received the US Food and Drug Administration (FDA) approval for Rykindo (risperidone) as 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.
The China-based pharmaceutical company developed Rykindo on its microsphere technology platform.
According to Luye Pharma, the medication uses long-acting and extended-release microsphere technology to deliver the active component risperidone. The drug is to be administered intramuscularly once every two weeks.
In 2021, Rykindo was cleared for marketing in China as a schizophrenia treatment. The development of the drug in Europe is going on, and there are plans to introduce the medication in additional nations and regions worldwide.
Rykindo will be the first commercially available therapy from Luye Pharma’s central nervous system (CNS) product portfolio in the US.
Luye Pharma president Yang Rongbing said: “Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and the society.
“Rykindo is our first new drug developed in-house and approved for marketing in the U.S., demonstrating our long-standing commitment to serving patients around the world with innovative therapies.
“At Luye Pharma, we continue to enrich our product portfolio in the CNS field by focusing on the unmet needs of patients, and we look forward to making further contributions to the mental health community by providing better care and better services to those in need.”
The Chinese pharmaceutical firm focuses on the CNS as a key therapeutic area. It also has a product portfolio for diseases such as depression, Parkinson’s disease, bipolar disorder, schizophrenia, and Alzheimer’s disease.