Multiomics Drug Approvals KP

Description: The Multiomics Drug Approvals KP, created and maintained by the Multiomics Provider, provides assertions about regulatory approvals of drug interventions for treating diseases, and observations of off-label use of drug interventions. These assertions and observations are derived through integration of content from DailyMed and the FDA's adverse-event reporting system (FAERS).

Example: The Multiomics Drug Approvals KP shows that leuprolide treats prostate cancer. This assertion is supported by 11 approved New Drug Applications, including NDA019732, and 7 product labels, including LEUPROLIDE ACETATE DEPOT- leuprolide acetate kit. The Multiomics Drug Approvals KP also shows that risperidone is applied to treat ADHD, off-label. This observation is supported by tens of thousands of case reports in FAERS.

Key methodologic metrics provided on edges: TBD.

The graph currently uses biolink:treats and biolink:applied_to_treat as predicates. Node categories include biolink:SmallMolecule, biolink:ChemicalEntity, and biolink:MolecularMixture for the interventions, and biolink:Disease and biolink:PhenotypicFeature for the conditions.

Modes of access: This BioThings API does not comply to the TRAPI standard. However, in collaboration with the Exploring Agent team, this BioThings API is accessible as a TRAPI KP service through:

• BioThings Explorer: https://biothings.ncats.io/multiomics_drug_approvals_kp (not up yet)
• SmartAPI: https://smart-api.info/ui/... TBD

In these situations, BioThings Explorer acts as a "TRAPI wrapper/transformer" that queries the BioThings APIs and processes their responses into knowledge-graphs that follow TRAPI and biolink-model standards (for node categories, edge predicates, etc).

Data Sources Used -

• FDA DailyMed
• FDA FAERS