FDA Approves Prior Approval Supplement for EGRIFTA SV
FDA action allows for unrestricted distribution of EGRIFTA SV, alleviating concerns of product batches
The approval comes after the recent FDA sanction of EGRIFTA WR™, a new formulation
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX), a leading biopharmaceutical company, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s Prior Approval Supplement (PAS) related to the supplemental biologics license application (sBLA) for EGRIFTA SV (tesamorelin for injection). This treatment is especially significant as it is the only FDA-approved option aimed at reducing excess abdominal fat in adults living with HIV and experiencing lipodystrophy.
This PAS approval marks a crucial step as it eliminates the previous regulatory requirements that restricted product release, allowing Theratechnologies to seamlessly resume the regular distribution of EGRIFTA SV. Additionally, the FDA has recently approved a new formulation of tesamorelin, referred to as EGRIFTA WR, which will replace the existing EGRIFTA SV and become available in the U.S.
“Receiving FDA approval for the Prior Approval Supplement related to EGRIFTA SV eliminates supply uncertainties, enabling us to return to standard supply conditions,” stated Paul Lévesque, President and CEO of Theratechnologies. “With the recent approval of EGRIFTA WR, we are excited about transitioning patients to this improved formulation, specifically designed to enhance their overall experience.”
Understanding EGRIFTA SV and the New EGRIFTA WR
Both EGRIFTA SV and the new EGRIFTA WR formulations utilize tesamorelin for injection, which is approved in the U.S. primarily for the reduction of excess abdominal fat in individuals with HIV who have lipodystrophy. Tesamorelin acts as a growth hormone-releasing factor (GHRF) analog, stimulating the pituitary cells in the brain to boost the production and release of endogenous growth hormone.
Though effective, recent assessments highlight important safety considerations associated with tesamorelin for injection. It is highly recommended for healthcare professionals to educate patients on these factors to inform their continued treatment journey.
Safety Information for EGRIFTA SV and EGRIFTA WR
Everyone using these therapies should be aware of some key safety information:
- The long-term cardiovascular safety profile of tesamorelin has not been firmly established. Healthcare providers should carefully evaluate the risk and benefits of therapy continuation, especially in patients who haven’t shown appreciable reductions in visceral fat.
- It is important to note that tesamorelin is not a solution for weight loss and exhibits a weight-neutral effect.
- Data does not confirm that there is improved adherence to anti-retroviral therapies when combined with tesamorelin treatment.
When considering treatment options with tesamorelin, it’s essential to analyze any contraindications:
- Patients with disruptions in the hypothalamic-pituitary axis due to conditions like hypophysectomy or head trauma should refrain from using tesamorelin.
- Individuals with active cancer, allergies to tesamorelin, or those who are pregnant are also advised against the use of this medication.
Common adverse reactions reported in connection with tesamorelin include joint pain, injection site discomfort, limb pain, water retention, and muscle aches. Healthcare providers and patients are encouraged to report any adverse events by calling 1-833-23THERA (1-833-238-4372).
About Theratechnologies
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) is committed to developing and providing innovative therapies that redefine care standards for patients. The firm focuses on commercializing unique remedies that address significant unmet medical needs, thus improving overall health outcomes for those it serves. For additional insights into Theratechnologies, visit their official website.
Frequently Asked Questions
What is the significance of the FDA approval for EGRIFTA SV?
The FDA approval for the PAS allows for the unrestricted distribution of EGRIFTA SV, resolving prior supply uncertainties.
How does EGRIFTA WR differ from EGRIFTA SV?
EGRIFTA WR is the new formulation of tesamorelin designed for improved patient experience and convenience compared to EGRIFTA SV.
Who is eligible to receive tesamorelin treatment?
Tesamorelin is intended for adults living with HIV and experiencing lipodystrophy, particularly those aiming to reduce excess abdominal fat.
What should patients know about the safety of tesamorelin?
Patients should understand potential cardiovascular risks and the medication’s weight-neutral effect, as it is not prescribed for weight loss purposes.
How can patients report adverse reactions to tesamorelin?
Healthcare providers and patients can report adverse events by contacting 1-833-23THERA (1-833-238-4372).
