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VPRIV PATIENT POPULATION

VPRIVʼs safety and efficacy were studied in the largest clinical trial program of an ERT for type 1 Gaucher disease across three clinical trials (n=99; aged ≥4 years)1–3

male patient
VPRIV has been evaluated during clinical trials in:
24
pediatric
patients
(4–17 years) in Study 0444
73
adult
patients
(≥18 years) in Study 0445
56
geriatric
patients
(≥65 years, including 10 patients
≥75 years) across all clinical studies1
Real-world experience data available in:
300+ pregnancies
Real-world data for VPRIV in over 300 pregnancies have not identified an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes.*1,6

Available data cannot definitively establish or exclude the absence of a VPRIV-associated risk
during pregnancy.1

*While available data cannot definitively establish or exclude the absence of a VPRIV-associated risk during pregnancy, these data have not identified an association with the use of VPRIV during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes1,6

These data have been reported in the pharmacovigilance database and published observational cohort studies, including the International Collaborative Gaucher Group Registry.1,6

VPRIV was evaluated across a diverse genotypic spectrum.7

In clinical trials, VPRIV was evaluated in patients with genotypic mutations associated with mild to severe disease.7,8

Population by GBA genotype before first dose in initial trials7

GBA GENOTYPE

GENOTYPE PREVALENCE

OVERALL
VPRIV
N=39 (%)

IMIGLUCERASE-
TO-VPRIV
N=16 (%)
Asn409Ser/Asn409Ser
Most common in the Ashkenazi Jewish and non-Jewish European population9,10
13 (33)
2 (13)
Asn409Ser/c.84dupG
Restricted to the Ashkenazi Jewish population9,10
1 (3)
0
Asn409Ser/Leu483Pro
Prevalent worldwide but lower chances of developing neuropathic disease9–11
2 (5)
1 (6)
Leu483Pro/Leu483Pro
Prevalent worldwide, associated with developing neuropathic disease9–11
2 (5)
2 (13)
Asn409Ser/other
Most common in the Ashkenazi Jewish and non-Jewish European population9,10
13 (33)
6 (38)
Leu483Pro/other
Prevalent worldwide9–11
3 (8)
0
F2131/F2131
Relatively rare in Ashkenazi Jewish populations, higher prevalence in Japanese populations12
0
2 (13)
Other/other
N/A
5 (13)
3 (19)

The GBA gene is responsible for the production of the glucocerebrosidase enzyme
GBA, glucosylceramidase beta

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.