Theratechnologies announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for EGRIFTA WR™, a new formulation of tesamorelin for injection designed to treat excess visceral abdominal fat in adults with HIV who have lipodystrophy.
The newly approved F8 formulation represents a significant advancement in patient convenience, requiring weekly reconstitution rather than the daily reconstitution needed with the current EGRIFTA SV® formulation. EGRIFTA WR™ also features a reduced administration volume—less than half that of its predecessor—while maintaining bioequivalence to the original tesamorelin formulation.
"We are pleased to offer this improved, more convenient version of tesamorelin for injection to help people with HIV and their healthcare providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. "EGRIFTA WR™ enables a simplified administration and an improved patient experience, which are important considerations for people living with HIV."
Improved Formulation Details
EGRIFTA WR™ will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose remains 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. A key advantage of the new formulation is its room temperature stability both before and after reconstitution, eliminating the need for refrigeration.
The most commonly reported adverse reactions include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia—consistent with the safety profile of previous formulations.
Dr. David Alain Wohl, Professor at the Institute of Global Health and Infectious Diseases at The University of North Carolina at Chapel Hill, commented on the clinical significance: "Central adiposity, characterized by the accumulation of excess visceral abdominal fat (EVAF), is a common complication for people with HIV that may result from the virus itself, from certain older antiretrovirals and from a reduction in growth hormone concentrations. Given the significant impact of EVAF on health and quality of life for many of our patients with HIV, and the importance of maintaining lean muscle mass especially as we age, a new, more conveniently dosed formulation of tesamorelin is a welcome advancement."
Clinical Implications for HIV Patients
Tesamorelin remains the only FDA-approved medication for reducing excess abdominal fat in adults with HIV-associated lipodystrophy. The condition, characterized by abnormal fat distribution, can significantly impact patients' quality of life and is associated with increased cardiovascular risk.
"The most important thing about this formulation is that it simplifies the regimen significantly," explained Dr. Marsolais in a recent interview. "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 new formulation is expected to improve patient adherence, a critical factor in managing HIV-associated comorbidities. "Patient adherence over the long term is crucial, particularly for those with excess visceral fat," Marsolais added. "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."
Beyond BMI: New Understanding of Cardiovascular Risk
The approval comes shortly after Theratechnologies presented important data at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) highlighting the limitations of using body mass index (BMI) as the sole indicator for cardiovascular risk assessment in people with HIV.
The Visceral Adiposity Measurement and Observation Study (VAMOS), a multicenter observational study of 170 people with HIV on antiretroviral therapy, found that excess visceral abdominal fat—defined as visceral adipose tissue surface area ≥130 cm²—was associated with increased 10-year atherosclerotic cardiovascular disease risk scores, even in participants with normal BMI.
"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," noted Dr. Marsolais.
These findings underscore the importance of treatments like EGRIFTA WR™ that specifically target visceral fat reduction in this patient population.
Manufacturing and Market Transition
EGRIFTA WR™ will be manufactured at a new U.S.-based contract drug manufacturing organization. The formulation is patent protected in the United States until 2033 and is set to replace the current EGRIFTA SV® formulation.
The approval follows the resolution of concerns raised in the FDA's January 2024 Complete Response Letter. After successful resubmission, the FDA concluded that the updated formulation meets the necessary standards for safety, efficacy, and manufacturing processes.
Looking Forward
As Theratechnologies prepares for the commercial launch of EGRIFTA WR™, the company is focusing on educating healthcare providers and patients about the benefits of the new formulation.
"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," said Dr. Marsolais. "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."
The company will also continue research efforts to enhance understanding of visceral adiposity and its impact on cardiovascular health in people living with HIV, with the goal of improving clinical decision-making and patient care.
It's important to note that EGRIFTA WR™ is not indicated for weight loss management, as it has a weight-neutral effect, and there are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking the medication. Additionally, the long-term cardiovascular safety of EGRIFTA WR™ has not been established.
