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Egrifta Approval Suggests Evolution In FDA Thinking On Role Of REMS

Executive Summary

FDA’s decision not to require a Risk Evaluation and Mitigation Strategy for Theratechnologies’ HIV lipodystrophy drug Egrifta (tesamorelin) suggests the agency is becoming more circumspect in how it applies its drug safety powers under the FDA Amendments Act more than two-and-a-half years after they took effect.

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Egrifta Approval: FDA Balanced Modest Efficacy, Off-Label Use Potential With Unmet Medical Need

The approval of Theratechnologies’ HIV lipodystrophy treatment Egrifta (tesamorelin) shows how much FDA can be swayed by unmet need, even where the product has limited efficacy in a narrow population and substantial potential for off-label use.

Egrifta Approval: FDA Balanced Modest Efficacy, Off-Label Use Potential With Unmet Medical Need

The approval of Theratechnologies’ HIV lipodystrophy treatment Egrifta (tesamorelin) shows how much FDA can be swayed by unmet need, even where the product has limited efficacy in a narrow population and substantial potential for off-label use.

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