Posted by Michael Wonder on 09 Oct 2020
NDA filing for Luye Pharma’s anti-depressant drug LY03005 accepted by the U.S. FDA
4 March 2020 - Luye Pharma Group has announced that the U.S. FDA has reviewed and accepted the filing of a new drug application for LY03005, a new chemical drug for the treatment of major depressive disorder.
LY03005 is the company's second drug in the central nervous system (CNS) therapeutic area currently in the U.S. FDA’s NDA phase.
LY03005 is an exclusive CNS product developed under Luye Pharma’s new chemical and therapeutic entities R&D platform, and is a serotonin-norepinephrine-dopamine triple reuptake inhibitor, with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor.
Luye Pharma has obtained patents covering the chemical compound, crystal form and formulation of LY03005. The patents relating to the chemical compound and crystal form have been granted in target markets such as China, the U.S., Europe, Japan and Korea.
