Last Thursday, March 14, Rezdiffra (resmetirom) became the first MASH drug approved in the US. A global panel of Key Opinion Leaders convenes to discuss their excitement about this approval, the opportunities it will create and some of the (largely manageable) challenges it might present.
00:00:00 - Surf's Up: Season 5 Episode 6
Opening introduction from an excited, enthusiastic panel, including brief quotes taken directly from the episode discussion.
00:05:02 - Groundbreakers
Each panelist shares one piece of good news from the previous week.
00:08:15 - Waiting for news and initial reactions
Panelists describe their moods throughout the day on March 14 and reactions when word of the approval came from FDA. They describe feeling varying degrees of trepidation as the day progressed without word from the agency, replaced by excitement and joy at the final announcement.
00:14:30 - Specific patients to target or avoid
Panelists describe the patients they expect to prescribe Rezdiffra for first (now for the US, when it becomes available for EMA). The group aligns on the benefits for F3 and F2 patients (the two groups listed on the label) but shares concerns about accurate identification of F3 vs. compensated cirrhosis.
00:17:07 - Impact on explaining lifestyle interventions
Zobair Younossi notes the historical difficulty of getting patients to view lifestyle modification as a specific prescription to be followed. He, Roger and Jeff all makes points to suggest that the combination of drug + lifestyle modification will be easier to explain to patients.
00:26:32 - Staging and screening patients using NITs
Laurent Castera joins the conversation as the topic switches to proper use of NITs. Previously, Jörn Schattenberg and Ian Rowe touched on challenges in deciding which patients have F3 fibrosis vs. early stage cirrhosis. Now the group explores the relative value of different strategies for qualifying patients. One key: while FIB-4 is an efficient screening test in largely negative populations, it produced a high level of false positives in specialty practices.
00:33:50 - How to educate providers
Roger points out that individual providers will conduct individual "clinical trials" in their own practices. This makes provider education on proper use critical to launch success. Louise Campbell commends Madrigal for the education pathway they laid out during the webcast. Jeff discusses the important role patients must play.
00:39:06 - Finding the initial patients
Apropos of education, Zobair points out that most early patients will be found in GI practices. Jeff points out that these patients are already in the system and can be easily identified.
00:43:12 - Why Rezdiffra's strong safety profile matters so much
Panelists agree that Rezdiffra's safety profile alleviates some concern that a well-meaning provider might prescribe for a patient with compensated cirrhosis due to inadequacy of current tests.
00:48:39 - Suggested takeaways for industry
Panelists suggest that industry learn from the large sample sizes and thoughtful use of NITs found in the Rezdiffra trial protocols.
00:52:20 - FDA and NITs
Louise asks how important FDA's two-day NIT workshop last year was in the agency not requiring biopsy prior to prescribing. Zobair says agency officials are moving slowly down a path toward greater acceptance.
00:53:53 - Closing Thoughts
Each panelist shares a closing thought. The topics vary widely.
01:01:06 - Question of the Week
The question is what impact Rezdiffra's approval will have on individuals' day-to-day work.
01:01:47 - Business report
News on audience metrics, future episodes and why there will be no Vault conversation this week
Last Thursday, March 14, Rezdiffra (resmetirom) became the first MASH drug approved in the US. A global panel of Key Opinion Leaders convenes to discuss their excitement about this approval, the opportunities it will create and some of the (largely manageable) challenges it might present.
00:00:00 - Surf's Up: Season 5 Episode 6
Opening introduction from an excited, enthusiastic panel, including brief quotes taken directly from the episode discussion.
00:05:02 - Groundbreakers
Each panelist shares one piece of good news from the previous week.
00:08:15 - Waiting for news and initial reactions
Panelists describe their moods throughout the day on March 14 and reactions when word of the approval came from FDA. They describe feeling varying degrees of trepidation as the day progressed without word from the agency, replaced by excitement and joy at the final announcement.
00:14:30 - Specific patients to target or avoid
Panelists describe the patients they expect to prescribe Rezdiffra for first (now for the US, when it becomes available for EMA). The group aligns on the benefits for F3 and F2 patients (the two groups listed on the label) but shares concerns about accurate identification of F3 vs. compensated cirrhosis.
00:17:07 - Impact on explaining lifestyle interventions
Zobair Younossi notes the historical difficulty of getting patients to view lifestyle modification as a specific prescription to be followed. He, Roger and Jeff all makes points to suggest that the combination of drug + lifestyle modification will be easier to explain to patients.
00:26:32 - Staging and screening patients using NITs
Laurent Castera joins the conversation as the topic switches to proper use of NITs. Previously, Jörn Schattenberg and Ian Rowe touched on challenges in deciding which patients have F3 fibrosis vs. early stage cirrhosis. Now the group explores the relative value of different strategies for qualifying patients. One key: while FIB-4 is an efficient screening test in largely negative populations, it produced a high level of false positives in specialty practices.
00:33:50 - How to educate providers
Roger points out that individual providers will conduct individual "clinical trials" in their own practices. This makes provider education on proper use critical to launch success. Louise Campbell commends Madrigal for the education pathway they laid out during the webcast. Jeff discusses the important role patients must play.
00:39:06 - Finding the initial patients
Apropos of education, Zobair points out that most early patients will be found in GI practices. Jeff points out that these patients are already in the system and can be easily identified.
00:43:12 - Why Rezdiffra's strong safety profile matters so much
Panelists agree that Rezdiffra's safety profile alleviates some concern that a well-meaning provider might prescribe for a patient with compensated cirrhosis due to inadequacy of current tests.
00:48:39 - Suggested takeaways for industry
Panelists suggest that industry learn from the large sample sizes and thoughtful use of NITs found in the Rezdiffra trial protocols.
00:52:20 - FDA and NITs
Louise asks how important FDA's two-day NIT workshop last year was in the agency not requiring biopsy prior to prescribing. Zobair says agency officials are moving slowly down a path toward greater acceptance.
00:53:53 - Closing Thoughts
Each panelist shares a closing thought. The topics vary widely.
01:01:06 - Question of the Week
The question is what impact Rezdiffra's approval will have on individuals' day-to-day work.
01:01:47 - Business report
News on audience metrics, future episodes and why there will be no Vault conversation this week