FDA experts back Novo Nordisk’s key diabetes drug

Novo Nordisk’s diabetes blockbuster-in-waiting semaglutide is edging closer to approval, after advisers to the US regulator unanimously voted in favour of approval.

The 16 experts from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favour of approval for the once-weekly GLP-1 injection, which is expected to generate peak sales in the region of $2 million if approved.

This now seems likely, as although the FDA is not bound by the decisions of its expert committees, it rarely goes against their recommendations when making regulatory decisions.

The FDA is due to make a decision on FDA before 5 December, paving the way for a launch early next year. Semaglutide is also under review in other major markets including Europe.

The panel made its recommendation on the basis of eight clinical trials from Novo’s SUSTAIN programme, including a cardiovascular outcomes trial.

Semaglutide is important to Novo Nordisk, as its daily GLP-1 drug Victoza is under pressure from Eli Lilly’s rival Trulicity.

Victoza had been market leader with global sales approaching $3 billion last year, but Trulicity is beginning to eat into this and is expected to generate sales of around $3.56 billion by 2022.

Semaglutide is Novo’s answer to this, and the Danish pharma is also hoping to put more pressure on its rivals with an oral formulation that is in late stage clinical development.

It will also compete against AstraZeneca’s older weekly GLP-1 drug, Bydureon (exenatide), and analysts forecast semaglutide sales in the region of $2 billion annually.

Semaglutide won’t have a cardiovascular protection indication as the SUSTAIN 6 was not sufficiently powered for this, as it was only designed to show cardiac safety compared with placebo.

But its label will refer to clinical data showing an overall 26% reduction in major cardiovascular events compared with placebo.

Novo plans to begin a large cardiovascular outcomes trial next year, in a bid to provide further information on semaglutide’s cardiovascular benefits and gain the coveted indication, which has recently been granted to Victoza.

The FDA approved a new indication for Victoza  to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease at the end of August.

In the SGLT2 inhibitor class of drugs, Lilly/Boehringer Ingelheim’s Jardiance was the first diabetes drug to show a cardiovascular protective effect in patients with established cardiovascular disease.

Johnson & Johnson’s Invokana has also been shown to reduce risk of cardiovascular events, but has been tarnished by trial results showing an elevated risk of lower limb amputation.

The FDA requires cardiovascular safety trials for all diabetes drugs, but pharma companies have turned this to their advantage by developing drugs that protect against heart attacks, strokes and cardiovascular death, as well as controlling blood sugar levels.

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