FDA declines to approve new form of HIV-associated lipodystrophy drug

2024-01-24

上市批准专利到期

Shares in Theratechnologies slid about 12% on Wednesday after it received a complete response letter (CRL) for a new simplified dosing form of Egrifta SV (tesamorelin), which is used to reduce excess abdominal fat in adults with HIV and lipodystrophy. The company said it plans to address the FDA's concerns and intends to resubmit an application for this new F8 version of the drug.

"While we are disappointed to receive a complete response letter…containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible," chief medical officer Christian Marsolais said in a statement Wednesday.

The filing submitted last September was supported by pharmacokinetic data showing the F8 version was bioequivalent to the original formulation, which was sold under the name Egrifta, but has since been replaced by Egrifta SV. Theratechnologies says the F8 form is eight times more concentrated than the original product, and twice as concentrated as Egrifta SV, allowing for smaller administration volumes and a multiple-dose vial that is reconstituted only once a week. It also has patent protection in the US until 2033, according to the company.

Manufacturing focus

Theratechnologies said questions in the CRL mainly pertain to chemistry, manufacturing, and controls (CMC), focusing on microbiology, assays, impurities, and stability for both the lyophilised product and the final reconstituted drug. The agency has also asked to see more information about how the new formulation might impact the risk of immunogenicity.

Jones Research, citing talks with Theratechnologies management, recently suggested that the F8 formulation could be launched within one month of FDA approval, while all patients on Egrifta SV could be transitioned to the new version in under six months.

Egrifta SV, which was approved by the FDA in 2018, is a growth hormone releasing factor analogue that acts on the brain's pituitary cells to stimulate the production and release of endogenous growth hormone. It is currently the only FDA-approved drug to help reduce visceral fat in adults with HIV and lipodystrophy. Theratechnologies said the CRL will not impact commercial availability of the drug.

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