S5 – E02.1 – Expectations For The Resmetirom PDUFA Date – The First MASH Drug Approval?

S5 - E02.1 - Expectations For The Resmetirom PDUFA Date - The First MASH Drug Approval?
Four leading MASLD patient advocates join Louise Campbell and Roger Green to discuss their expectations for the resmetirom PDUFA data and, with it, the potential for the first MASH drug approval.

Leading patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) discuss their expectations for life after the resmetirom PDUFA data and, with it, the potential for the first MASH drug approval, with Louise Campbell and Roger Green.

The conversation starts with Roger noting a funny coincidence; the March 14 PDUFA data for resmetirom is Pi Day, which means the first MASH drug approval might come on the math geek’s favorite day of the year. He asks panelists to describe their moods as they look forward to the event. All five other panelists Advocates describe their “guarded optimism” regarding whether resmetirom will be approved. Wayne Eskridge also notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise Campbell and Milan Mishkovikj describe how US approval might affect their respective countries and regions. Going last, Jeff McIntyre describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. When he has finished discussing the questions we might all face arouind the initial FDA ruling on resmetirom, he goes on to describe a possible approval path for countries outside the US.

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