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Victoza comes up big for Novo with key heart-risk lowering data

On Friday, Novo Nordisk announced that its own med, GLP-1 treatment Victoza, significantly reduced the combined incidence of heart attack, stroke and cardiovascular death in high-risk Type 2 diabetes patients

Full results from Novo's LEADER trial--which tracked more than 9,000 patients over a period of up to 5 years--won't be unveiled until this June's American Diabetes Association annual meeting.

But in the meantime, Novo is "very excited" about the top-line data, company R&D chief Mads Krogsgaard Thomsen said in a statement.

And it has good reason to be. Last August, SGLT2 contender Jardiance became the first diabetes med to cut down 38% on CV risk, a status some analysts said could shake up the diabetes landscape in a big way. And there was plenty of pressure on Victoza to do the same: In September, Leerink Partners analyst Seamus Fernandez predicted "moderately negative impact to overall GLP-1 sales" if Victoza couldn't pull it of

Now, though, Novo is hoping it can capitalize on some of the sales success industry-watchers have predicted for Jardiance and its SGLT2 brethren. And as Thomsen said last year on an earnings call, because Victoza and Jardiance work differently--GLP-1 drugs stimulate insulin production, whereas SGLT2s help patients excrete blood sugar through urine--any positive CV effects for his company's therapy could be for a different--and potentially better--reason.

"My view is that it's more interesting to have an agent that, if it can interfere in the vessel wall pathology due to … [the] maladies that are ongoing in the Type 2 diabetic body, then that would be a long-term investment for the patient because you would get the legacy or the memory effect of the drug that once was used, unlike a diuretic which works when it's given and stops working after it's given the last time," he said.

LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term effects of Victoza® (1.2 and 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of cardiovascular events. The trial was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries that were followed for 3.5-5 years. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

From www.fiercepharma.com

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