Main phase – 26 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week main phase of the combined studies

In Phase 3 clinical studies, patients receiving tesamorelin for injection had an increased risk of developing diabetes (HBA1c level ≥6.5%) at week 26 vs placebo (4.5% vs 1.3%); Hazard ratio: 3.3 (95% CI: 1.4, 9.6).

Discontinuation rates due to adverse reactions

At 26 weeks

9.6%

of patients receiving tesamorelin for injection discontinued

*The safety of EGRIFTA SV™ (2 mg/vial formulation) have been established based on clinical trials conducted with EGRIFTA^® (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV™ are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA^®.

Extension phase – 52 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week extension phase of the combined studies (week 26 to week 52)

Discontinuation rates due to adverse reactions

At 52 weeks

(During the second 26 weeks of the trial)

2.4%

of patients receiving tesamorelin for injection discontinued

View the clinical study design

In a post-hoc responder analysis of two multicenter, randomized, placebo-controlled trials,

Adverse Reactions

Incidence of adverse events occurring in ≥5% and more frequently in responders than in non-responders¹

Over 52 weeks, responders (≥8% reduction in excess abdominal fat) experienced²:

EGRIFTA SV™ is not indicated to reduce glucose or triglyceride levels.

The results of the post-hoc analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA^®.

In two multicenter, randomized, placebo-controlled trials:

Adverse Reactions

Main phase – 26 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week main phase of the combined studies

Discontinuation rates due to adverse reactions

9.6%

of patients receiving tesamorelin for injection discontinued

Extension phase – 52 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week extension phase of the combined studies (week 26 to week 52)

Discontinuation rates due to adverse reactions

2.4%

of patients receiving tesamorelin for injection discontinued

View the clinical study design

In a post-hoc responder analysis of two multicenter, randomized, placebo-controlled trials,

Adverse Reactions

Incidence of adverse events occurring in ≥5% and more frequently in responders than in non-responders¹

EGRIFTA SV™ is not indicated to reduce glucose or triglyceride levels.

The results of the post-hoc analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA^®.

View the post-hoc analysis design

In two multicenter, randomized, placebo-controlled trials:

Adverse Reactions

Main phase – 26 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week main phase of the combined studies

Discontinuation rates due to adverse reactions

9.6%

of patients receiving tesamorelin for injection discontinued

Extension phase – 52 weeks

Incidence (%) of adverse reactions occurring in ≥2% and more frequently in patients receiving tesamorelin for injection during the 26-week extension phase of the combined studies (week 26 to week 52)

Discontinuation rates due to adverse reactions

2.4%

of patients receiving tesamorelin for injection discontinued

View the clinical study design

In a post-hoc responder analysis of two multicenter, randomized, placebo-controlled trials,

Adverse Reactions

Incidence of adverse events occurring in ≥5% and more frequently in responders than in non-responders1

EGRIFTA SV™ is not indicated to reduce glucose or triglyceride levels.

The results of the post-hoc analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA®.

View the post-hoc analysis design

Incidence of adverse events occurring in ≥5% and more frequently in responders than in non-responders¹

The results of the post-hoc analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA^®.