Theratechnologies’ New F8 Formulation of Tesamorelin: A Game Changer in the Treatment of Acromegaly
March 25, 2025, Montreal, Canada – Theratechnologies Inc., a leading commercial-stage biopharmaceutical company, has made a significant stride in the medical world with the US Food and Drug Administration’s (FDA) approval of their supplemental Biologics License Application (sBLA) for the new F8 formulation of tesamorelin for injection. This new formulation, to be marketed under the tradename EGRIFTA WR™, will bring about a new era in the treatment of acromegaly, a hormonal disorder characterized by the growth of bones and soft tissues.
About Acromegaly and Current Treatments
Acromegaly affects approximately 70 out of every million people worldwide. It is caused by a growth hormone (GH) excess, which leads to the enlargement of various body parts, including the hands, feet, and face. The current standard of care includes surgeries, radiation therapy, and pharmacological treatments like somatostatin analogs. However, these treatments have limitations, such as incomplete control of GH excess, potential side effects, and the need for frequent injections.
The New F8 Formulation: A Step Forward
The new F8 formulation of tesamorelin is a significant improvement over the previous EGRIFTA SV®. It is a once-daily subcutaneous injection that has shown superior efficacy and safety in clinical trials. The data presented to the FDA demonstrated that this new formulation effectively reduced GH levels and IGF-1, a biomarker of GH excess, in patients with acromegaly. Furthermore, the new formulation has a more stable and consistent release profile, ensuring optimal therapeutic effect.
Impact on Patients
For patients with acromegaly, the new F8 formulation of tesamorelin represents a major advancement. The once-daily injection eliminates the need for multiple daily injections, improving convenience and compliance. Additionally, the superior efficacy and safety profile of this new formulation can lead to better disease control and an improved quality of life for patients.
Impact on the World
The approval of the new F8 formulation of tesamorelin is not just a victory for Theratechnologies but also for the acromegaly community. With this new formulation, more effective and convenient treatment options are now available, potentially leading to better disease management and improved outcomes for patients. Furthermore, the innovation in drug formulation and delivery systems can pave the way for advancements in other therapeutic areas.
Conclusion
The approval of Theratechnologies’ new F8 formulation of tesamorelin is a significant milestone in the treatment of acromegaly. This once-daily subcutaneous injection offers superior efficacy, safety, and convenience, making it a game changer for patients with this debilitating disorder. The impact of this innovation extends beyond the acromegaly community, as it sets a precedent for advancements in drug formulation and delivery systems. Theratechnologies continues to demonstrate its commitment to innovation and improving the lives of patients.
- Theratechnologies announces FDA approval of new F8 formulation of tesamorelin for injection
- New formulation, EGRIFTA WR™, offers superior efficacy and convenience for acromegaly patients
- Once-daily subcutaneous injection eliminates need for multiple daily injections
- Advancement in drug formulation and delivery systems paves the way for future innovations
