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Todd Hobbs Part 2, How Close Is An Oral GLP1 To Being FDA Approved




In part 2 of this Exclusive Interview, Todd Hobbs talks with Diabetes in Control Publisher Steve Freed about the standings of the oral GLP-1 drug and their work on another oral drug.

Todd Hobbs is vice president and US Chief Medical Officer for Novo Nordisk.

 

Transcript of this video segment:

Steve Freed: Having an oral GLP-1 is exciting, there’s been so much written about it. Where is that product right now, as far as coming to the FDA for approval?

Todd Hobbs: So we have 10 trials and the last one that will complete this year is Pioneer 6, and we expect that result by the end of the year, very close to the end of the year. So then we’ll put the data together, get the file ready and we’ve anticipated filing in 2019; as you would imagine probably not early 2019 because it’s going to take some time to get that together, and we’ll file that in 2019 and then as you know with the FDA it could be a short process sometimes but usually a more lengthy 10 to 12 month process, and we’ll have to see once we get to that. Next year at ADA I can probably give you more information on where we are with that.

Steve Freed: So you’re working on an oral product. Are you working on the next SGLT-2 with a GLP-1 combination?

Todd Hobbs: Currently we don’t have any assets in our portfolio that are SGLT-2 pills so we’re not looking at that combination now. We are studying them and used together, separately; in different of the Pioneer trials there are patients who may be on SGLT-2s and have the GLP-1 added, but we don’t own an SGLT-2 and aren’t looking to combine that with our oral semaglutide. The process to get oral delivery of a protein or peptide is not that easy, as you can imagine. And we’ve been working on this for decades so trying to combine that with another individual agent would be another challenge, and we certainly have not yet looked at that.

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