Glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent a type 2 diabetes (T2D) injectable drug class that is increasingly prescribed to patients on oral anti-diabetic treatments who are struggling to get their blood glucose levels under control. The current GLP-1RA market leader, Novo Nordisk’s Victoza (liraglutide), generated global sales of more than $3B in 2017.

GlobalData believes that growth in the GLP-1RA space will be heavily driven by agents that confer glycemic benefit, non-glycemic benefits such as weight loss and cardiovascular (CV) benefit, and increased patient compliance. Recent results from the PIONEER 1 study, a Phase IIIa clinical trial investigating Novo Nordisk’s NN9924, a novel formulation of semaglutide, indicates that the agent is already proving to fulfil most of the aforementioned criteria, potentially resulting in the agent becoming the new market leader in the GLP-1RA space within the next decade.

The GLP-1 RA class continues to undergo major diversification, primarily regarding mode of administration. Historically, the class was made up of agents that were delivered via once or twice daily injections, but in the past few years, novel marketed GLP-1RAs have begun to offer once weekly administration. Unfortunately for Novo Nordisk, once-weekly GLP-1RA competitors, such as Eli Lilly’s Trulicity (dulaglutide), continue to steal market share from Victoza.

In anticipation of GLP-1RA market trends, Novo Nordisk developed a follow-up once-weekly GLP-1RA of its own, Ozempic (semaglutide), which is a variant of Victoza that was shown to significantly reduce CV risk in T2D patients in the SUSTAIN-6 trial. In addition, Novo Nordisk is developing NN9924, an oral version of semaglutide, which is on track to become the first-to-market oral GLP-1RA.

At the 54th EASD annual meeting in Berlin, it was announced that the PIONEER trial, which enrolled 8,845 T2D patients, showed significant benefits (glycemic efficacy and weight loss) conferred by NN9924. The study also resulted in no unexpected safety and tolerability issues, with NN9924’s safety profile closely resembling those of fellow GLP-1RAs. But what sets NN9924 apart from its competitors is its route of administration.

The oral GLP-1RA has an obvious advantage in terms of administration, as the marketed GLP-1 RAs are administered via injection, and thus are prone to heightened compliance issues. At the conference session, the only issue raised pertaining to NN9924 was that the agent needs to be taken before breakfast, which may affect the timing of other medications that are taken. Overall, NN9924 is expected to achieve blockbuster status if approved, despite stiff competition from existing GLP-1RAs.

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