Novo Nordisk Annual Report 2021
Contents Introducing Novo Nordisk
Strategic Aspirations Key risks
Management
Consolidated statements
Additional information.
Novo Nordisk Annual Report 2021 28
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Research and
development progress
Diabetes
Regulatory events
- A market authorisation application was resubmitted to
the FDA for approval of semaglutide 2.0 mg May 2021.
-Approval by the EU of Ozempic 2.0 mg.
-Xultophy was approved in China for diabetes
management.
- OzempicⓇ was approved in China for diabetes
management.
- A label extension for Insulatard® and ActrapidⓇ was
submitted to EMA to increase the non-refrigerated
storage time prior to opening by 4 weeks.
Clinical progress
- A phase 3b trial was initiated with high dose Rybelsus®,
25 and 50 mg, in people with type 2 diabetes (T2D).
-The phase 3a programme, COMBINE, was initiated
investigating the once-daily combination of Icodec and
semaglutide in people with T2D.
- Phase 3a, ONWARDS trials were initiated investigating
once-weekly Icodec in people with type 1 (T1D) and
(T2D).
- A Phase 2 trial was initiated to investigate the effects
of the combination of semaglutide and novel GIP in
people with T2D.
- A Phase 2 trial was initiated to investigate the effects
of the combination of semaglutide and cagrilintide in
people with (T2D).
- A Phase 1 trial for glucose sensitive insulin was
completed.
- A Phase 1 trial was initiated to investigate tolerogenic
DNA plasmid in for preventive treatment of diabetes in
people with T1D.
Obesity
Regulatory events
- Once-weekly sc semaglutide 2.4 mg was approved
under the brand name Wegovy for weight
management in adults with obesity or overweight and
at least one weight-related comorbidity in the US. A
marketing authorisation application for semaglutide
2.4 mg obesity was submitted to the Japanese Health
Authorities and approved in the EU.
- SaxendaⓇ was granted a label expansion to include the
use in adolescents (aged 12 to <18 years) with obesity
or overweight in the US and Europe.
Clinical progress
- A phase 3a trial was initiated to investigate the effects
of once-weekly sc semaglutide 2.4 mg on physical
function, symptoms and body weight in people with
obesity-related heart failure with preserved ejection
fraction (HFPEF).
- A phase 3a trial OASIS-1 was initiated to investigate
oral semaglutide 50 mg in people with obesity.
Biopharm
Regulatory events
-The once-weekly growth hormone derivative,
somapacitan, was approved in Japan and Europe for
adults with growth hormone deficiency.
- Regulatory file to support a prophylaxis indication for
Rebinyn was submitted.
- Regulatory file to support a new indication for
NovoSeven in women with Postpartum haemorrhage
was submitted.
Clinical progress
- Initial results from the phase 3a programme, REAL
4; investigating the once-weekly growth hormone
derivative, somapacitan, in children with Growth
Hormone Deficiency (GHD) were compiled.
- Results from a phase 2 trial, REAL 5, in children, with
short stature and born short for gestational age were
compiled.
- First cohorts of phase 1/2 trial with Mim8 successfully
completed.
- A phase 3a trial for macimorelin was initiated
investigating an oral diagnostic agent used for the
diagnosis of GHD in adolescents and children.
Other serious chronic diseases
Clinical progress
- A phase 3a programme, ESSENCE, was initiated
investigating once-weekly semaglutide in people with
Non-alcoholic steatohepatitis (NASH).
- A phase 3a programme, EVOKE, was initiated
investigating once-weekly semaglutide in people with
Alzheimer's Disease.
- A phase 3a cardiovascular outcome trial, ZEUS, was
initiated investigating once-monthly monoclonal
antibody Ziltivekimab in people with Atherosclerotic
Cardiovascular Disease (ASCVD), Chronic Kidney
Disease (CKD) and residual inflammatory risk.
- In collaboration with Gilead, a phase 2b trial was
initiated investigating semaglutide in combination
with Gileads investigational FXR agonist cilofexor and
investigational ACC inhibitor firsocostat in people with
compensated cirrhosis (F4) due to NASH.
- A phase 2 trial was initiated investigating orally
administrated PCSK9i for LDL-cholesterol lowering in
people with ASCVD or general CV risk.
- Novo Nordisk acquired phase 2 ready antibody PRX004
for the rare heart disease ATTR cardiomyopathy from
Prothena Corporation PLC.
- A phase 2 trial was initiated investigating once-weekly
FGF21 in people with NASH. As part of phase 2 trial
an additional treatment arm with Cagrilintide in
combination with semaglutide is included in the trial.
- Collaboration with Staten Biotechnology terminated.View entire presentation