Biologics License Application for F8 Formulation of Tesamorelin Rejected by FDA

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The FDA has issued a complete response letter (CRL) to Theratechnologies Inc. in response to a supplemental Biologics License Application (sBLA) for a newer F8 formulation of tesamorelin.¹

Tesamorelin, sold under the brand name Egrifta, was approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.²

Theratechnologies said it will address the FDA’s request and will continue to seek approval for the new formulation of tesamorelin.

“While we are disappointed to receive a [CRL] from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible,” Christian Marsolais, PhD, senior vice president and chief medical officer at Theratechnologies, said in a press release. “We remain focused on bringing this new formulation of tesamorelin to market as part of our commitment to innovate and simplify treatments for people with HIV.”¹

The concerns raised in the CRL for the sBLA are mainly associated with the chemistry, manufacturing, and controls regarding the microbiology, assays, impurities, and stability for the lyophilized product and the final reconstituted drug product, according to Theratechnologies. Further, the FDA is asking for additional information to evaluate the potential impact of the proposed formulation on immunogenicity risk.

Egrifta SV has been approved by the FDA to lower excess abdominal fat in HIV-infected adults with lipodystrophy. Lipodystrophy is a condition associated with some antiretroviral medications that are commonly administered to patients with. 

Lipodystrophy causes excessive adipose tissue to develop in certain areas of the body.² The growth hormone releasing factor (GHRF) analog acts on pituitary cells in the brain to stimulate endogenous growth hormone production and release.

Egrifta has shown potency that is comparable to endogenous GHRF. Egrifta stimulates the secretion of growth hormone in a similar fashion to endogenous growth hormone-releasing factors, which act on pituitary cells to synthesize and release growth hormone.

References

1. Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA. Theratechnologies Inc. News release. January 24, 2024. Accessed January 25, 2024. https://www.theratech.com/news-releases/news-release-details/theratechnologies-receives-complete-response-letter-crl-fda-f8

2. Belisle, C. Patel, A. Pharmacy Times. Theratechnologies Inc's Egrifta. February 2011. Infectious Disease. Volume 77. Issue 2. Accessed January 25, 2024. https://www.pharmacytimes.com/view/rxprofile_egrifta