The FDA has approved Theratechnologies’ supplemental Biologics License Application (sBLA) for EGRIFTA WR (Tesamorelin F8), a treatment for excess visceral abdominal fat in adults with HIV-associated lipodystrophy. This new formulation replaces EGRIFTA SV, offering weekly reconstitution instead of daily, making it more convenient for patients.
Clinical and Pharmacological Advancements: Tesamorelin F8 maintains bioequivalence to the original tesamorelin formulation and requires less than half the injection volume of its predecessor. As a growth hormone-releasing factor (GHRF) analog, it stimulates endogenous growth hormone production to reduce visceral adipose tissue. Common adverse reactions include arthralgia, injection site reactions, pain in extremities, peripheral edema, and myalgia.
In our interview with Christian Marsolais, PhD, senior vice president and chief medical officer at Theratechnologies, he said, “The most important thing about this formulation is that it simplifies the regimen significantly. In the past, patients had to reconstitute their dosage daily. Now, with the F8 formulation, they will only need to do so once a week, with a much smaller volume for daily administration, making it more comfortable and user-friendly.”
The F8 formulation was approved following a thorough FDA review of its sBLA after addressing concerns raised in the agency’s January 2024 Complete Response Letter (CRL). The FDA concluded that the updated formulation meets the necessary standards for safety, efficacy, and manufacturing.
“The F8 formulation has similar efficacy and safety as the previous one, but with better convenience,” added Marsolais. “The smaller volume of administration is more comfortable, and the simplified process should improve long-term adherence, allowing patients to stay on treatment longer for better outcomes.”
The new formulation of tesamorelin offers a simplified, long-acting dosing regimen, which is expected to improve patient adherence compared to previous treatment options. A single dose of the F8 formulation now provides effective treatment for up to 56 weeks, marking a significant advancement over the existing therapies.
“Patient adherence over the long term is crucial, particularly for those with excess visceral fat,” Marsolais said. “Data shows there is a significant need for consistent treatment to manage comorbidities like lipodystrophy. By improving patient adherence, we can help them stay on treatment longer, which can make a real difference in their health.”
EGRIFTA SV is not indicated for weight loss or for improving adherence to antiretroviral therapy. Long-term cardiovascular safety has not been established. Hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, myalgia, and peripheral edema.
Limitations of BMI in Cardiovascular Risk Assessment for People with HIV
At the 2025 CROI conference in San Francisco, California, Theratechnologies presented data highlighting the limitations of using body mass index (BMI) as a sole indicator for cardiovascular (CV) risk in people with HIV (PWH). The study, part of the Visceral Adiposity Measurement and Observation Study (VAMOS), emphasized the role of excess visceral abdominal fat (EVAF) in driving cardiovascular risk, irrespective of BMI classification.
Marsolais also noted, “Recent data presented at CROI shows that BMI is not a good marker for assessing visceral fat. Waist circumference is a better tool, and our medical team is working to educate physicians on this new science to ensure patients benefit from improved treatment strategies.”
The VAMOS study, a multicenter observational study of 170 PWH with virological suppression on antiretroviral therapy (ART), found that EVAF, defined as a visceral adipose tissue (VAT) surface area ≥130 cm², was associated with increased 10-year atherosclerotic cardiovascular disease (ASCVD) risk scores, even in participants with normal BMI. This finding underscores that BMI alone does not capture the full scope of CV risk in this population. A significant proportion of PWH with normal or overweight BMI had high EVAF, which correlated strongly with increased pericardial fat volume (PFV), a key predictor of cardiovascular complications.
These findings suggest the need for more accurate screening tools to assess CV risk in PWH, including measuring waist circumference or other indicators of visceral fat. This study calls for a shift in clinical practice to better identify individuals at risk and improve cardiovascular outcomes in this vulnerable group.
Marsolais emphasized the importance of these advancements and shared insights on the next steps for the company, “As we move forward, our next steps involve ensuring the successful launch of the F8 formulation and educating both healthcare providers and patients on its benefits. This includes working closely with our marketing and medical teams to improve understanding of the formulation, its advantages, and how it can lead to better patient outcomes. Additionally, we will continue to gather and share new scientific data, particularly on assessing visceral adiposity and its impact on cardiovascular health, to enhance clinical decision-making and patient care.”
