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The Risks Of Surrogacy: Egrifta Faces Twofold Challenge At Advisory Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

Theratechnologies will need to address FDA's concerns about whether a reduction of patients' visceral abdominal fat produced by the HIV lipodystrophy product has clinical meaning and is worth the risks.

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Egrifta Post-marketing Study On Diabetic Retinopathy Will Include CV Outcomes

FDA’s decision to require a post-approval clinical trial evaluating the cardiovascular effects of Theratechnologies’ HIV lipodystrophy drug Egrifta shows the agency has overcome concerns – both its own and those of its advisory committee – that such a study could not be feasibly and ethically conducted.

Egrifta Post-marketing Study On Diabetic Retinopathy Will Include CV Outcomes

FDA’s decision to require a post-approval clinical trial evaluating the cardiovascular effects of Theratechnologies’ HIV lipodystrophy drug Egrifta shows the agency has overcome concerns – both its own and those of its advisory committee – that such a study could not be feasibly and ethically conducted.

Delayed Egrifta Approval Brings Clean Label, No REMS For Theratechnologies

Tesamorelin becomes the first drug approved by FDA to treat HIV-related lipodystrophy.

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