FDA approval of the first MASH drug, Rezdiffra, on March 14 marked what co-host and Key Opinion Leader Jörn Schattenberg describes as a "watershed moment" for hepatology. This opening discussion covers how panelists heard the news of Rezdiffra's approval, how they reacted, and their initial thoughts about appropriate patient targets.
As the conversation starts, the various panelists describe their moves throughout the day on March 14th and their reactions when word of the FDA's approval came. They all describe having felt various degrees of trepidation as the day progressed. Jeff McIntyre describes him and his friends as "constantly refreshing our screens" throughout the day. Zobair Younossi probably felt less anxiety than others, while some of the Europeans described feeling more.
This was replaced by excitement and joy at the final announcement. Jörn Schattenberg describes the day as a "watershed moment," that, in Zobair's words, "energiz[ed] for the entire field."
Panelists go on to describe the patients they expect to prescribe Rezdiffra for at launch (now for the US, whatever comes available on the EMR). Jörn intends to prescribe initially for F3 patients but realizes he might not know exactly how to distinguish them from early-stage cirrhosis. Zobair points to prescribing for F2 and F3 patients as indicated in the label.
FDA approval of the first MASH drug, Rezdiffra, on March 14 marked what co-host and Key Opinion Leader Jörn Schattenberg describes as a "watershed moment" for hepatology. This opening discussion covers how panelists heard the news of Rezdiffra's approval, how they reacted, and their initial thoughts about appropriate patient targets.
As the conversation starts, the various panelists describe their moves throughout the day on March 14th and their reactions when word of the FDA's approval came. They all describe having felt various degrees of trepidation as the day progressed. Jeff McIntyre describes him and his friends as "constantly refreshing our screens" throughout the day. Zobair Younossi probably felt less anxiety than others, while some of the Europeans described feeling more.
This was replaced by excitement and joy at the final announcement. Jörn Schattenberg describes the day as a "watershed moment," that, in Zobair's words, "energiz[ed] for the entire field."
Panelists go on to describe the patients they expect to prescribe Rezdiffra for at launch (now for the US, whatever comes available on the EMR). Jörn intends to prescribe initially for F3 patients but realizes he might not know exactly how to distinguish them from early-stage cirrhosis. Zobair points to prescribing for F2 and F3 patients as indicated in the label.