CMD22 Capital Markets Day
7
Commercial execution and innovation
NASH and Alzheimer's disease
Novo Nordisk is supporting use of non-invasive tests for
diagnosis
Development and adoption of non-invasive tests (NITS)
Liver biopsy
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NITS
Guidelines: NITS represented in guidelines
Practitioners: ~80% of HCPs perform NASH diagnostics with use of
various NITs, while biopsies are seldomly used
NIT development: Several available NITs in clinical practice. ELF test is
first prognostic tool to be granted FDA De Novo marketing
authorisation
Pharma companies: Embedding validation of NITs in clinical trials
Novo NordiskⓇ
Novo Nordisk activities supporting non-invasive tests in NASH diagnosis
External
Real world
Linking biomarkers and liver histology to outcomes
Disease understanding
Consortia
Collaborations with academia and other healthcare companies
NN Development
Phase 2 trial with FGF21
Phase 3 ESSENCE trial (part 1 and 2), incl. screening data
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19
Validate
diagnostic tests
Validate
tests for monitoring
Validate tests
for prognosis
Note: FDA De Novo provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no
legally marketed predicate device.
NITS: Non-invasive tests; NASH: Non-alcoholic hepatitis; HCPs: Healthcare professionals; FDA: the US Food and Drug Agency; NN: Novo Nordisk; ELF: Enhanced liver fibrosis
CMD22
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