Developing Oral Semaglutide for Treatment of T2D

Oral semaglutide and the multitude of results from the Pioneer trials are among the most discussed topics at the American Diabetes Association (ADA) 2019 Scientific Sessions in San Francisco, CA.

In the PIONEER trials, oral semaglutide was pitted against a wide array of common treatments, including empagliflozin and liraglutide, for type 2 diabetes. Novo Nordisk submitted a new drug application for oral semaglutide to the US Food and Drug Administration in March.

Using their priority waiver voucher, Novo Nordisk is hopeful that oral semaglutide could be approved as early as September 2019 and could receive approval for cardiovascular implications in early 2020.

While at ADA 2019, Todd Hobbs, MD, chief medical officer at Novo Nordisk North America, sat with MD Magazine® and discussed what has prompted the push to develop an oral diabetes treatment and what the impact on clinical practice would be if oral semaglutide is approved.

MD Mag: What prompted the development of oral semaglutide and is there a time for approval?

Hobbs: As we've been dealing with insulin for almost 100 years and now injectable peptide like GLP1. We know the injection bearer is a burden and, in particular, for patients to go on injection that's a huge hurdle. Also for providers and primary care providers, in particular the time it takes the comfort level starting injections is a big barrier and we see that in the fact that that there really is not the level of prescribing and use of GLP1s that you would expect based on their profile and place in therapy and the in the guidelines.

So, our goal and our hope with this program is that again we would really open up GLP1 use and the benefits of that in a1c and weight and convenience. You know, an oral therapy that again patients could benefit from that hopefully primary care physicians are going to be much more comfortable starting and prescribing and again, that would open up significantly the numbers of patients that could benefit from the therapy next step.

So, certainly we were working with FDA to go through the multiple filings as you reported on the diabetes filing we did use our Priority Review voucher so we're looking at potentially a mid-September answer and it's never a guarantee so we're going to work with them and make sure that we give them any data they need. Then, for the cardiovascular filings those are the standard sNDA filings that go up to a year so we're going to continue to work with them on looking at semaglutide as a molecule how it looks in regard to cardiovascular benefits. So, looking at both injectable Ozempic (semaglutide) for a CV indication but also the oral semaglutide for cv indication. So, we have a lot going on with FDA and we're hopeful that that's going to mean good news sometime this year and then early next year for even the cardiovascular answer as well.