AstraZeneca Results Presentation Deck
Respiratory & Immunology: R&D pipeline highlights
Potential to change standards of care
25
Saphnelo
Systemic lupus erythematosus
Received US and Japan approval
• AHEG scheduled ahead of EU
regulatory decision
Phase III trial for subcutaneous
delivery underway
NDC 0310-3040-00
Be only
Saphnel
Saphnelo™
(anifrolumab-fnia)
Injection
For Intravenous Infusion After Dilution,
Must dilute before use. See prescribing information.
Single-dose vial Discard unused portion
Store refrigerated at 2°C to 8°C (36°F to 467).
Ceep vial in original carton to protect from light.
Jo not shake or freeze
Rx only
300 mg/2 ml
(150 mg/ml)
single-dose vial
AstraZeneca
PT027
Asthma
Positive phase III results from both
MANDALA and DENALI trials
Potentially the first albuterol/ICS
combination rescue therapy for
the US
• Positioned to replace traditional
rescue SABA approach with
as-needed albuterol/ICS to treat
underlying inflammation
Regulatory submission
anticipated in H1 2022
Tezepelumab
Asthma
Regulatory submission completed
in US, EU and Japan
Regulatory decisions expected
H1 2022
Orphan Drug Designation in US -
eosinophilic oesophagitis
Phase III trial in
nasal polyps underway
AHEG = ad-hoc expert group; ICS = inhaled corticosteroid; SABA = short acting beta agonist. PT027 is being developed in collaboration with Avillion Inc. Tezepelumab is being developed in collaboration with Amgen Inc.
US FDA
Priority
Review
received
for asthma
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