Novo aiming for blockbuster sales for FDA-approved semaglutide

Novo Nordisk’s weekly GLP-1 diabetes injection semaglutide has been approved by the US regulator, a potential blockbuster that the firm hopes will allow it to regain market share from Lilly's rival.

The FDA approved has approved the drug, to be known as Ozempic, as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

Approval is based on the results from the SUSTAIN clinical trial programme and follows a unanimous recommendation from the FDA’s Metabolic Drugs Advisory Committee meeting in October.

In people with type 2 diabetes, Ozempic produced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, Merck & Co’s Januvia (sitagliptin), Bydureon and Sanofi’s Lantus (insulin glargine U100).

The company has announced that the drug will cost $676 per prescription, which it described as “at parity” with drugs in the same class.

Novo’s Victoza (liraglutide) generated sales of around $2.85 billion last year and is the market-leading GLP-1 drug.

But Eli Lilly’s rival from the same class, Trulicity (dulaglutide) has proved a hit since its US launch around three years ago, and its 2017  revenues will exceed $1 billion.

Analysts from Evaluate Pharma expect Trulicity to outsell Victoza by around 2022.

AstraZeneca’s weekly Bydureon (exenatide) is also well established on the GLP-1 market but Novo hopes Ozempic will begin taking sales from all of these following some strong safety and efficacy data from phase 3 trials.

In the trials, treatment with Ozempic resulted in statistically significant reductions in body weight.

Ozempic demonstrated a safe and well-tolerated profile across the SUSTAIN programme with the most common adverse event being mild to moderate nausea, which diminished over time.

Novo is also conducting trials to explore the drug's cardiac benefits - a crucial component for any new diabetes drug entering the market today.

While Novo will be able to refer to this data on the clinical section of the drug’s label, it must conduct a suitable powered trial before the FDA will grant semaglutide a cardio protection indication on its label.

[caption id="attachment_22462" align="alignnone" width="223"] Lilly and Boehringer Ingelheim's Jardiance[/caption]

This would bring it into contention with Eli Lilly/Boehringer’s Jardiance (empagliflozin), the first diabetes drug to show a cardio benefit in adults with established cardiovascular disease. Victoza also gained this indication earlier this year.

Ozempic is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched in a special pen.

Novo Nordisk will, as part of the post-approval requirements, conduct a paediatric trial in adolescents under 18 years of age and will add Ozempic to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all other long-acting GLP-1 products.