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Clinical Data

In two multicenter, randomized, double‑blind, placebo‑controlled trials:

Patients who received EGRIFTA® experienced a significant reduction in excess visceral abdominal fat up to 18%1†‡

Main Phase 26 weeks
16%

Average reduction in excess visceral abdominal fat†‡

Extension Phase 52 weeks
18%

Group assignments are denoted as Main Phase‑Extension Phase.

An expert panel in agreement with the FDA determined that a ≥8% decrease in excess visceral abdominal fat was clinically significant2

The safety and effectiveness of EGRIFTA SV® has been established based on adequate and well‑controlled studies with EGRIFTA® (tesamorelin for injection).

EGRIFTA SV® is weight‑neutral and may increase lean body mass by up to 5 pounds1,3

In a post‑hoc responder analysis†‡ of data from two multicenter, randomized, double‑blind, placebo‑controlled clinical trials:

EGRIFTA® responders experienced a significant reduction in excess visceral abdominal fat and waist circumference at 26 weeks that was maintained for up to 52 weeks3†‡

Main Phase 26 weeks
27%

Average reduction in excess visceral abdominal fat†‡

Extension Phase 52 weeks
31%

Among responders, excess visceral abdominal fat:3‡

  • Decreased (187 cm2 to 137 cm2) towards normal levels (<130 cm2) by Week 26.
  • On average (129 ± 48 cm2), was within normal levels of visceral abdominal fat at Week 52.

Excess visceral abdominal fat, cm2

Main Phase
(Baseline – Week 26)		Extension Phase
(Week 26 – Week 52)
Responders
(n=232)		Non-responders
(n=105)		Responders
(n=110)		Non-responders
(n=42)
Baseline187 ± 82193 ± 84190 ± 79163 ± 70
Change from Baseline to Week 26-50 ± 3416 ± 28-61 ± 4811 ± 23
% Change~27% reduction~8% increase~31% reduction~7% increase

Definition of responders3

In this post‑hoc analysis, responders were determined independently at Weeks 26 and 52.

  • A per‑protocol analysis of adherent patients (>80% compliance with daily EGRIFTA® injections) was used to analyze the clinical effects of EGRIFTA®
  • The per‑protocol population included patients who had no major protocol violations and underwent ≥1 post‑dose abdominal CT scan for excess visceral abdominal fat measurement
  • As specified a priori in the data analysis plan, a decrease of ≥8% was used to define “responders”2

The results of the post‑hoc responder analysis were not part of the NDA, and therefore were not reviewed by the FDA to support the approval of EGRIFTA®.

The safety and effectiveness of EGRIFTA SV® has been established based on adequate and well‑controlled studies with EGRIFTA® (tesamorelin for injection).

EGRIFTA SV® is not indicated for weight loss management.

EGRIFTA SV® is not approved for use in clinical conditions other than the reduction of excess abdominal fat.

FDA = Food and Drug Administration; NDA = New Drug Application.
† In two multicenter, randomized, placebo‑controlled trials. The primary outcome for these trials was change from Week 26 to Week 52 in excess visceral abdominal fat by treatment group (EGRIFTA® Week 0–52 or EGRIFTA® Week 0–26 and placebo Week 26–52). See complete study design below.
‡ A single‑slice CT scan was used to quantify excess visceral abdominal fat.

Clinical study design

EGRIFTA® was studied in two multicenter, randomized, double‑blind, placebo‑controlled clinical trials1

Main inclusion criteria1†

  • HIV-positive adults, 18‑65 years old
  • Excess abdominal fat accumulation
  • Stable ART for ≥8 weeks prior to baseline

The safety and effectiveness of EGRIFTA SV® has been established based on adequate and well‑controlled studies with EGRIFTA® (tesamorelin for injection).

In the Main Phase studies:1

  • 543 patients received EGRIFTA®
  • 263 patients received placebo

ART = antiretroviral therapy; BMI = body mass index; E =EGRIFTA®; FBG = fasting blood glucose; P = placebo.
† Key exclusion criteria included FBG >150 mg/dL (>8.33 mmol/L), BMI ≤20 kg/m2, diabetes type 1 or insulin‑treated type 2, use of insulin‑sensitizing agent, or a history of malignancy or active neoplasm.
‡ 816 were included and underwent randomization, 806 received treatment as assigned.

References:

  1. EGRIFTA SV® (tesamorelin for injection) Prescribing Information. Theratechnologies Inc. October 2019.
  2. Snyder SW. Regulatory Considerations for the Treatment of Lipodystrophy. Report of a Forum for Collaborative HIV Research Roundtable discussion. October 25, 2004; Washington DC.
  3. Stanley TL, Falutz J, Marsolais C, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV‑infected patients receiving tesamorelin. Clin Infect Dis. 2012;54(11):1642-1651.

Learn more about the THERA patient support® Program.

IMPORTANT SAFETY INFORMATION (Please see below for full limitations of use and additional important safety information)

Indication

EGRIFTA SV® is indicated for the reduction of excess abdominal fat in HIV‑infected adult patients with lipodystrophy.

Limitations of Use:

  • The impact and safety of EGRIFTA SV® on cardiovascular health have not been studied.
  • EGRIFTA SV® is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA SV® helps improve compliance with anti‑retroviral medications.

Contraindications:

Do not use EGRIFTA SV® if patient:

  • Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or a head injury.
  • Has active cancer.
  • Is allergic to tesamorelin or any of the ingredients in EGRIFTA SV®.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

Drug Interactions

Use in Specific Populations

Adverse Reactions

The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.

To report suspected adverse reactions, contact THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for EGRIFTA SV®.