BEQVEZ™ Adverse Reactions

(fidanacogene elaparvovec-dzkt)

6 ADVERSE REACTIONS

The most common adverse reaction (incidence ≥5%) reported in clinical studies was an increase in transaminases.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BEQVEZ was evaluated in 60 [45 patients in clinical study 1 (NCT03861273) and 15 patients in clinical study 2 (NCT02484092)] patients who received the recommended dose (5 × 1011 vg/kg) in two open-label clinical studies.

No serious adverse reactions were reported in patients treated with BEQVEZ. The most common adverse reactions observed in ≥5% of patients post-dose are listed in Table 3:

Table 3. Adverse Reactions (Incidence ≥5%) Following Treatment with BEQVEZ
*
Includes terms alanine transaminase (ALT) increased, aspartate transaminase (AST) increased, hepatic enzyme increased, hepatic function abnormal, liver function test abnormal, transaminases increased.

Adverse Reactions

Clinical Study 1

Patients (%)

(N=45)

Clinical Study 2

Patients (%)

(N=15)

Transaminases increased*

24 (53.3%)

2 (13.3%)

Not all transaminase elevations were reported as adverse reactions [see Warnings and Precautions (5.1)].

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Adverse Reactions

6 ADVERSE REACTIONS

The most common adverse reaction (incidence ≥5%) reported in clinical studies was an increase in transaminases.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BEQVEZ was evaluated in 60 [45 patients in clinical study 1 (NCT03861273) and 15 patients in clinical study 2 (NCT02484092)] patients who received the recommended dose (5 × 1011 vg/kg) in two open-label clinical studies.

No serious adverse reactions were reported in patients treated with BEQVEZ. The most common adverse reactions observed in ≥5% of patients post-dose are listed in Table 3:

Table 3. Adverse Reactions (Incidence ≥5%) Following Treatment with BEQVEZ
*
Includes terms alanine transaminase (ALT) increased, aspartate transaminase (AST) increased, hepatic enzyme increased, hepatic function abnormal, liver function test abnormal, transaminases increased.

Adverse Reactions

Clinical Study 1

Patients (%)

(N=45)

Clinical Study 2

Patients (%)

(N=15)

Transaminases increased*

24 (53.3%)

2 (13.3%)

Not all transaminase elevations were reported as adverse reactions [see Warnings and Precautions (5.1)].

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