Novo Nordisk Gets FDA Panel's OK for Diabetes Drug

Group votes unanimously to recommend approval of drug to compete with Eli Lilly

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Oct 20, 2017
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Novo Nordisk A/S (NVO, Financial) just announced that an FDA advisory panel has voted in favor of the approval of one of its lead diabetes assets and the company is picking up some favorable attention in the space on the back of the news.

Why is this development so important for Novo, and what does it mean for the company and the diabetes space going forward?

The drug, semaglutide, is a diabetes target. It is Novo's answer to some already relatively well-established blockbuster assets in the space right now, most notably Trulicity from Eli Lilly & Co. (LLY, Financial).

Semaglutide is a GLP-1 receptor agonist. GLP-1 receptors are expressed in pancreatic beta cells, which are the cells responsible for the synthesis and release of insulin. By agonizing (or exciting, to put it another way) the receptors on the cells, you can increase the amount of insulin produced.

This is in contrast to the other standard of care diabetes therapy of direct insulin injection, whereby the insulin is introduced to the body as opposed to the body itself being stimulated to produce insulin.

Semaglutide doesn’t have a commercial name yet, but it's going to be in direct competition with Trulicity. The development program that underpins the application was set up in anticipation of this competition. Specifically, Novo compared its asset to Eli Lilly’s in a head-to-head Phase 3 and it came out on top in several different metrics. The data showed that the drug reduced mean glucose from baseline to a higher degree than did Trulicity and that the safety profile of the two drugs was pretty much the same.

Heading into the AdCom meeting, the potential for Novo's drug to cause diabetic retinopathy was a bit of a concern, but as the 16-0 vote suggests, this doesn’t look like it's going to be a major concern.

Semaglutide can probably wrestle market share from Trulicity, based on the fact that both assets are once-weekly injections but that the latter can have some long-term cardiac benefits in type 2 diabetes patients.

Of note, Trulicity has been pulling market share from one of Novo's previously approved GLP-1 assets, Victoza, since its approval in 2014. Victoza is a daily injection as opposed to the once-weekly injection required by Trulicity. With Novo Nordisk now fighting back with its own once-weekly, the program has come full circle.

The PDUFA (Prescription Drug User Fee Act) date for the drug is Dec. 5, at which point we will find out if the FDA agrees with the recommendation of its panel.

But things don't stop there.

Semaglutide could just be a precursor to what could be a far higher impact development over the coming two years. Novo is trying to develop an oral formulation of the same drug and expects to file for approval for its oral semaglutide at some point during 2020.

Oral diabetes treatments have the potential to revolutionize the way that patients treat their conditions, but the development of these assets has proven extremely tough to date. Novo previously dropped an oral insulin formulation that it had developed through phase 2 for unknown reasons. Oral insulin is hard to produce because the fragility of insulin means it gets broken down in the GI tract if unprotected. Oral GLP-1 drugs are tough to create because of the high dose required to ensure enough active compound reaches the pancreatic beta cells.

Novo conducted a phase 2 trial on oral semaglutide that completed this month and the results look strong.

So oral GLP-1 looks like it could soon be available, but what about oral insulin?

Oral insulin might actually be available even sooner than its GLP-1 counterpart. Oramed Pharmaceuticals Inc. (ORMP, Financial) has developed a drug called ORMD-0801 that seeks to overcome the issues generally associated with oral administration. Enteric coating and protease inhibitors reinforce the security of the insulin that's encapsulated in the pill.

Just as with Novo's oral semaglitude, Oramed's oral insulin pill, ORMD-0801, recently completed a phase 2 trial and the data was also strong, as Oramed’s share price has been recently. The drug was able to reduce weighted mean nighttime glucose, the primary endpoint of the study, and the trial suggested that an oral insulin pill can be used to get insulin directly to the liver without it being rendered inactive by the body on its way there.

Again, just as with Novo's asset, ORMD-0801 is just about to head into a global phase 3 study with the data derived from this study set to underpin a Biologics License Application (BLA) in the U.S. post-trial completion.

The company recently sat down with the FDA to put together a protocol for the study and the meeting resolved successfully, giving the company a clear path to commercialization in the U.S.

While Novo Nordisk looks set to wrestle back the market share of the injectable diabetes market that it lost to Eli Lilly through Trulicity, the market could, within two years, be in for a much larger fundamental shift toward oral treatment, if Novo and Oramed can successfully complete their pivotal trials.

Disclosure: Long Novo Nordisk and Oramed Pharmaceuticals.