Publication date: Oct 10, 2024
“We are pleased that FDA has recognized our innovative biomarker approach and will continue to work with the agency to bring this biomarker-based precision medicine to TRD patients. Denovo’s discovery of a novel pharmacogenomic biomarker, DGM4, presents a new era for liafensine, a first-in-class triple reuptake inhibitor. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are firstinclass drugs with global rights. Over 30% patients with MDD do not benefit from currently available antidepressants and are diagnosed with treatment-resistant depression (TRD). “This FDA Fast Track designation is an accelerator for liafensine’s development,” said Xiao-Xiong Lu, PhD, Denovo’s Chief Technical Officer. Furthermore, clinicians have challenges identifying the appropriate therapies that most likely benefit these patients. “About Treatment-Resistant DepressionMore than 23 million people in the US alone suffer from major depressive disorder (MDD).
| Concepts | Keywords |
|---|---|
| Biopharmaceutical | Biomarker |
| Download | Biopharma |
| News | Db104 |
| Schizophrenia | Denovo |
| Depression | |
| Designation | |
| Drugs | |
| Fast | |
| Fda | |
| Liafensine | |
| Patients | |
| Resistant | |
| Track | |
| Trd | |
| Treatment |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | Depression |
| drug | DRUGBANK | Nonoxynol-9 |
| drug | DRUGBANK | Methionine |
| disease | MESH | psychiatric diseases |
| disease | MESH | dissociation |
| disease | MESH | respiratory depression |
| disease | MESH | movement disorders |
| disease | MESH | weight gain |
| disease | MESH | major depressive disorder |
| drug | DRUGBANK | Serotonin |
| drug | DRUGBANK | Norepinephrine |
| drug | DRUGBANK | Dopamine |
| disease | MESH | schizophrenia |
| drug | DRUGBANK | Spinosad |
| disease | MESH | central nervous system diseases |
| drug | DRUGBANK | Coenzyme M |