Posted by Michael Wonder on 01 Apr 2019
Luye Pharma's Rykindo expected to be the first Chinese innovative drug to receive U.S. FDA approval
28 March 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for Rykindo, completed on March 28.
Rykindo (LY03004) risperidone extended-release microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.
The submission for Rykindo is regarded as a milestone step for the company, expecting a big pay-off from the potential industrialisation of its long-invested long-acting and extended-release technology R&D platform. This is not only a key step in Luye Pharma's globalisation initiative, but also a major step for China in bringing innovative formulations to the world, receiving wide attention from all walks of life. After going through R&D, CMC and process optimisation testing, the scaling-up of production, registration review and commercial preparations, Luye Pharma is now fully prepared for the global launch of Rykindo and other innovative formulations.
Rykindo is an extended-release microsphere independently developed by Luye Pharma. It is administered once every two weeks by intramuscular injection to treat schizophrenia and bipolar disorder. The NDA submission this time includes the results from one pivotal and two supportive clinical studies, involving a total of 172 patients in the U.S.
