A Green Light from FDA for Oral Semaglutide

Holy grail? Game-changer? These superlatives were flying around as FDA approved Rybelsus – oral semaglutide – yesterday for type 2 diabetes. We don’t know about all that puffery, but it’s clear enough that this approval is a big deal. Oral semaglutide will be the first ever GLP-1 agonist in a pill. Up until now, taking this type of drug required an injection.

Perhaps we don’t have to tell you this. Most people really hate needles. And even so, GLP-1 drugs have been hugely successful for type 2 diabetes. One of them, liraglutide (sold as Saxenda), has come to dominate the market for anti-obesity medicines.

Taking away the needle, we think Rybelsus will open the door for even more sales growth.

Capping a Week of Good News

This approval caps a week of good news for semaglutide. Researchers presented two impressive studies of injectable semaglutide at the European Association for the Study of Diabetes. At the same time, they published the full results in two respected medical journals.

First, the SUSTAIN 8 study went to press in the Lancet Diabetes and Endocrinology. It showed that weekly semaglutide (Ozempic) injections gave better outcomes versus canagliflozin. Sold under the name of Invokana, canagliflozin is an SGLT2 inhibitor in an oral tablet. Patients who received weekly semaglutide injections had better control of blood sugar and also better weight outcomes.

As we’ve previously written, early results with semaglutide for obesity have been quite encouraging.

Second, results of the SUSTAIN 10 study showed that weekly semaglutide injections were superior to daily injections with liraglutide (Victoza) for type 2 diabetes. Just as it did versus canagliflozin, semaglutide yielded better control of blood sugar and better weight outcomes than liraglutide did.

It’s little wonder that Ozempic is selling briskly after little more than a year on the market.

The Question of Cost

The mixed news this week for oral semaglutide came from ICER – the Institute for Clinical and Economic Review. In a draft report, ICER said that oral semaglutide might offer an “incremental benefit” over other options. But ICER also said that “other treatments may provide better overall benefit and at lower cost.”

It all comes down to the price that Novo Nordisk sets for their promising new drug. Novo Nordisk isn’t saying yet. The company has only said that “Rybelsus will be competitively priced within the GLP-1 category.”

One to Watch

Oral semaglutide will be an important drug to watch. It may offer important gains for people living with type 2 diabetes. Eventually, it may offer even more important gains for people with obesity. But we have much to learn before we know if any of that will be true.

Click here and here for more on the Rybelsus approval. For more about the ICER report, click here. Finally, you can find the full prescribing information (the package insert) for Rybelsus here.

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September 21, 2019