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Novo Nordisk gets FDA nod for once-weekly rival to Lilly’s Trulicity

GLP-1 agonist Ozempic approved in the US for type 2 diabetes

Novo Nordisk

The US FDA has approved Novo Nordisk’s once-weekly GLP-1 agonist Ozempic for type 2 diabetes, setting up a marketing clash with Eli Lilly’s fast-growing Trulicity rival.

Ozempic (semaglutide) has been approved by the US regulator as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes, after a unanimous vote by an FDA advisory committee in October.

It is being trumpeted by Novo as a ‘new standard’ in type 2 diabetes after beating Trulicity (dulaglutide) in a phase III head-to-head trial, threatening the position of one of Lilly’s brightest growth prospects.

EvaluatePharma has predicted Ozempic could become a $2.2bn product by 2022, while some other analysts believe it could do better and top $3bn at peak. That could pose a big competitive threat to Trulicity, which is one of Lilly’s top-performing new products with sales rocketing 135% to $1.38bn in the first nine months of the year mainly because of its dosing advantage versus daily GLP-1 drugs like Novo’s Victoza (liraglutide).

In the head-to-head trial Ozempic outperformed its rival on the main endpoint of reducing haemoglobin A1c levels – a marker for glucose control – when added to treatment with metformin, and also helped patients lose more weight than Lilly’s drug, according to Novo.

That weight-loss advantage could help the company make a stronger marketing case for Ozempic and help it overcome payer resistance in the diabetes category, ensuring a rapid take-up, according to analysts.

"Type 2 diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease,” commented Novo’s chief science officer Mads Krogsgaard Thomsen, adding the new drug would be launched on the US market early next year.

Ozempic is also under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. Novo has previously said it intends to price the drug in the same ballpark as other GLP agonist products.

Article by
Phil Taylor

6th December 2017

From: Regulatory

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