S5-7.3 – Patient advocacy and the Rezdiffra label

S5-7.3 - Patient advocacy and the Rezdiffra label
Patient advocates, led by GLI's Jeff McIntyre, discuss advocates' goals for a MASH drug label and the steps they took to communicate this information to FDA.

This conversation focuses on the steps that patient advocates took to educate the FDA on what patients wanted in a MASH drug label, in this case for Rezdiffra.

It starts with Jeff McIntyre reflecting on apparent changes in how the FDA thinks about labeling since the initial obeticholic acid Complete Response Letter in 2020. His specific point: since that first CRL, GLI has worked closely with patient advocates, including those on this call, to educate the FDA on what their endpoints and considerations were around safety and efficacy and to help get Rezdiffra approved in the way that brings maximum benefit to patients. He points to biopsy as one proof point. More important, he believes the advocacy from patients has led to an approval process and label that “de-risks” the MASLD space for future investment.

The other panelists agree. Wayne Eskridge points back to biopsy as a particularly critical issue. Jenn Jones believes the collective effort has improved accessibility as well. Tony Villiotti acknowledges a concern that the FDA had been “dismissive” during the Obeticholic Acid Advisory Committee last year and describes himself as “pleasantly surprised” by the patient centricity of the final Rezdiffra label. Louise Campbell says this label might become a “game changer” if it signals that Madrigal will help MASH patients, most of whom live with co-morbidities, get support in navigating their array of issues.

As the conversation ends, Roger Green makes a specific point that Madrigal’s offer to support medical exceptions signifies a deep understanding of the actual challenges to early uptake and a commitment to do better than companies in the past.

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