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Analysts have notably mixed opinions on the commercial opportunity, but one of the more intriguing near-term catalysts for Novo Nordisk is potential FDA approval of Victoza (its GLP-1 anti-diabetic) for the treatment of obesity.
Most recent Phase III data – published in May – supports a consensus view that Victoza will be filed for obesity and stands a strong chance of gaining approval. Whether regulatory progress can translate into commercial success remains to be seen, however.
Versus placebo (in the 56-week SCALE study), Victoza demonstrated a statistically significant difference in obese non-diabetic patients, including average weight loss of 8 percent for Victoza compared to 2.6 percent for placebo. Furthermore, 64 percent of Victoza patients achieved greater than 5 percent weight loss and 33 percent achieved greater than 10 percent weight loss. Mean weight loss of 5.4 percent was above the 5 percent threshold required by the FDA.
However, perhaps the most significant data from SCALE pointed to Victoza's potential use in pre-diabetes patients. Of the 61 percent of patients with pre-diabetes at randomisation, 69 percent treated with Victoza no longer showed signs of diabetes compared to 33 percent for placebo (at 56 weeks). Furthermore, for patients without pre-diabetes at the start of the study, the chance of developing pre-diabetes was reduced from 21 percent with placebo to 7 percent with Victoza.
Analysts have suggested that this data could potentially differentiate Victoza in the obesity setting, assuming approval is secured. Possibly offsetting this benefit is the likely more expensive cost of Novo Nordisk's product and its administration via injection (versus the cheaper cost and oral availability of competing obesity treatments).
Commercial expectations for Victoza in obesity were dealt something of a blow when the drug failed to demonstrate compelling data in obese diabetes patients. Nevertheless, analyst models currently reflect a broad perception of uptake for obesity in non-diabetic patients, ranging from no revenue contribution to peak sales in excess of $1 billion.
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With filing expected to occur in the US within the next few months, this week's Physician Views poll targets general practitioners and internal medicine specialists based in the US to gauge their current perception to use of a GLP-1 agonist for the treatment of obesity.
• How would you describe the impact of new obesity treatments (Qsymia, Belviq) in terms of the overall efficacy of available therapies?
• Have you ever prescribed a GLP-1 agonist (i.e. Victoza) in an off-label capacity for the treatment of obesity?
• If approved for the treatment of obesity (and based on available Phase III data), in what percentage of obese patients would you consider prescribing Victoza?
• If approved for the treatment of obesity (and based on available Phase III clinical data), in what percentage of pre-diabetic obese patients would you consider prescribing Victoza?
• What factors would act to limit your use of liraglutide for the broader treatment of obesity (i.e. among both pre-diabetes and non pre-diabetes patients)
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