Specialty Care Pipeline
The agents and uses mentioned below are investigational and have not been approved by the US Food and Drug Administration (FDA) for the uses under investigation. No conclusions regarding safety and efficacy should be drawn for such agents and uses.
The Sanofi Specialty Care pipeline includes new molecular entities as well as potential new indications for existing products. The graphic below summarizes the expected (as of September 30th, 2023) global submission timeline for each product and indication.
Expected Global Submission Timeline (as of September 30, 2023)
2023
Kevzaraa
Polyarticular juvenile idiopathic arthritis
2024
Dupixenta
COPD
tolebrutinib
SPMS
Sarclisa
1L Newly Diag. MM Ti (IMROZ)
venglustat
GM2 gangliosidosis
rilzabrutinib
ITP
fitusiran
Hemophilia A/B
tolebrutinib
RMS
MenQuadfi
6w+
2025 and beyond
Dupixenta
CPUO
Nexviazyme
Pompe Disease - Infantile Onset
Dupixenta
Bullous pemphigoid
venglustat
Gaucher Type 3
Kevzaraa
Systemic juvenile arthritis
venglustat
Fabry Disease
amlitelimab
Atopic dermatitis
fitusiran
Hemophilia A/B ped
itepekimaba
COPD
VRVg
Purified vero rabies vaccine
Sarclisa
Smoldering MM
SP0125
RSV toddler
Sarclisa SubQ
3L RR MM (IRAKLIA)
SP0202
Pneumococcal
tolebrutinib
PPMS
SP0218
Yellow fever
frexalimab
MS
Immuno-inflammation
Oncology
Rare Diseases
Neurology
Rare Blood Disorders
Vaccines
aDeveloped in collaboration with Regeneron.
1/2/3L=first/second/third line; COPD=chronic obstructive pulmonary disease; CPUO=chronic pruritus of unknown origin; ITP=immune
thrombocytopenia; MM=multiple myeloma; NSCLC=non-small cell lung cancer; PPMS=primary progressive MS; RMS=relapsing MS;
RR=relapsing/remitting; SPMS=secondary progressive MS; SubQ=subcutaneous; Te=transplant eligible; Ti=transplant ineligible.