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Novo Nordisk gets another OK for oral GLP-1 drug Rybelsus

Drug is first and so far only oral alternative to injectable GLP-1 agonists

Novo Nordisk

Novo Nordisk’s oral GLP-1 agonist Rybelsus – a key part of plans to inject growth into its diabetes franchise – has been approved for marketing in Japan.

The green light from the Japanese Ministry of Health, Labour and Welfare (MHLW) follows an FDA approval for Rybelsus (semaglutide) last October, and a recommendation for approval in the EU in February.

Rybelsus is the first and so far only oral alternative to injectable GLP-1 agonists such as Eli Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Ozempic (semaglutide) and Victoza (liraglutide), and has been tipped as a future blockbuster brand.

Novo Nordisk has a lot riding on the new drug, as the company’s diabetes franchise has been hit by competition from Trulicity as well as downwards pressure on pricing in the US from payers.

Rybelsus has been approved in Japan on the back of the PIONEER clinical trial programme, which was run in 9,500 subjects, including 1,300 patients in Japan.

In the study, a 7mg once-daily dose of Rybelsus was equivalent to once-weekly Trulicity in controlling blood sugar, while a 14mg daily dose outperformed Trulicity and Victoza, which is injected once daily.

Novo Nordisk will now start pricing negotiations in Japan ahead of a future launch, which will be carried out by the company in collaboration with Merck & Co/MSD, its co-promotion partner for the drug.

New data from the PIONEER programme reported at the American Diabetes Association sessions earlier this month revealed that Rybelsus was more effective at reducing blood sugar and body weight in type 2 diabetics than Merck & Co’s oral DPP-4 inhibitor Januvia (sitagliptin), Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance (empagliflozin), as well as Victoza.

Analysts think that clinical profile and patient-friendly dosing could elevate Rybelsus into a $2bn-plus product, with some estimating it could go even higher.

A recent note from Pareto Securities analyst Johan Unnerus forecasts 2026 revenues in excess of $5bn, which would make it a larger product than Victoza at its peak.

Rybelsus still has a long way to go before it reaches those heady heights. In the first quarter of this year the drug brought in around $45m, while Victoza and Ozempic contributed around $750m and $716m, respectively.

Novo Nordisk is hoping that collective data from the PIONEER trials programme could help it get a cardiovascular outcomes claim for Rybelsus later this year, which could help accelerate sales growth.

That won’t match Ozempic and Trulicity which have approvals based on dedicated trials on reducing  the risk of major adverse cardiovascular events (MACE) in type 2 diabetes patients with heart disease. Novo Nordisk is conducting a dedicated trial for Rybelsus in this setting – SOUL – but that isn’t due to generate results until 2024.

Article by
Phil Taylor

30th June 2020

From: Regulatory



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