Novartis Q4 Results
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Company overview
Financial review
Conclusions
Appendix
FabhaltaⓇ1: FDA approved with compelling label in PNH
Positive early launch signals, expect modest ramp
Strong product profile reflected in label
Compelling data
.
References
•
.
Hb improvement vs. C5i in patients
with residual anemia
Transfusion avoidance
Comprehensive IVH and EVH control
Broad population
Oral administration
First oral monotherapy
REMS requirements similar to
other complement inhibitors
·
Adults with PNH
.
Naive and switch
300781189209
GROWTH
FABHALTA
(iptacopan)
200 mg
capsules
Reco
NDC 0078-1189-20
Rx only Eest
FABHALTA
(iptacopan) capsules Ston
екси
and
200 mg
Dispenso with accompanying
Medication Guide.
60 capsules
Swallow the capsules whole. Do not
open, break, or chew capsules
NOVARTIS
mac
DE
E
.
Demonstrated safety profile
Positive early launch signals, expect modest ramp
Launch execution
•
Promotion started early Dec incl. at ASH
.
REMS and patient support programs live
First patients initiated shortly after approval
Sentiment
·
Positive HCP sentiment on efficacy,
safety and oral profile
Strong interest from patients/patient groups
Access
•
Distribution with two national specialty
pharmacies
Bridge support in place pending payer
coverage
PNH
-
paroxysmal nocturnal hemoglobinuria. C5i complement 5 inhibitor. IVH - intravascular hemolysis. EVH - extravascular hemolysis. REMS-risk evaluation and mitigation strategies.
HCP - healthcare professional. 1. Iptacopan is the generic name for unapproved indications.
□ NOVARTIS | Reimagining Medicine.
ASH American Society of Hematology.
Novartis Q4 Results | January 31, 2024
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