elafibranor FDA and EMA approvals estimation

Ipsen re-iterated the FDA PDUFA (June 10, 2024) and estimated EMA approval in 2H 2024 during their Q1 2024 earnings call.

From the Q&A session:

• Q: Now that seladelpar is in the hands of Gilead, how might that influence negotiations when it comes to access? 

• “Obviously Gilead is a formidable competitor because they have a long history in hepatology, however, more in mass markets hepatology than in rare disease. PBC is a rare disease so we think what’s going to happen with two strong players in that space is actually going to accelerate the expansion on the market, which is something which is positive for patients for sure, because you have two companies really working on that. And then how the market share is going to pan out, we will see. What I can say is that where we have faced well-known companies like for example, we have Novartis for somatostatin but we have also Pfizer and MSD against Cabometyx. We were able still to have a number one position. So you know, we will see how this is going to pan out.”

• Q: Thoughts on any risks regarding elafibranor’s approval, any chance for an ad-com? Can you give us any insight on the label? 

• “I would say the ad-com is now highly unlikely because I mean, we are very advanced in the process. And you know, with June 10 PDUFA date, we are starting to get very close to it. So I think it's highly unlikely that we're going to have an advisory committee. On each component of the label, I obviously for competitive reasons, I cannot comment on this. So you know, labor proposal has gone in. We are following the process now and we are looking forward to then communicate on the robustness of labor once we get the approval.”

source: press release; webcast; Q1 2024 highlights