FDA approves Luye Pharma’s Rykindo for schizophrenia and bipolar 1 disorder

The U.S. Food and Drug Administration (FDA) has approved Luye Pharma’s Rykindo (risperidone) for extended-release injectable suspension 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 its 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.

Schizophrenia and bipolar disorder are both severe mental disorders. There were 40 million sufferers of bipolar disorder worldwide in 2019, and currently around 24 million schizophrenia patients. In the U.S., the estimated prevalence of schizophrenia and related psychotic disorders ranges between 0.25% and 0.64%, while an estimated 4.4% of U.S. adults experience bipolar disorder at some point in their lives.

“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,” said Yang Rongbing, president of Luye Pharma Group.

“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.”

Rykindo was approved for marketing in China in 2021 for the treatment of schizophrenia. The development of Rykindo in Europe is progressing, with plans to launch the drug in more countries and regions around the world.

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