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Novo Nordisk’s Xultophy Expected to See High Growth in 2018

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Xultophy’s revenue trends

In fiscal 2017, Novo Nordisk’s (NVO) Xultophy generated revenues of 729 million Danish kroner compared to 207 million Danish kroner in 2016. That’s a ~255% YoY (year-over-year) growth in local currency.

The expansion of international operations and solid growth in Europe primarily attributed to Xultophy’s revenue growth. Presently, Xultophy is approved in 18 countries.

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Recent developments

In 1Q18, Novo Nordisk completed its DUAL III Japan Phase 3a trial with Xultophy. In the trial, Xultophy demonstrated superiority over Tresiba in lowering Hb1Ac levels with a ~2% reduction of A1c. Also, individuals on Xultophy therapy experienced a weight loss of 0.7 kg (kilograms) compared to a weight gain of 0.7 kg for individuals on Tresiba therapy from the mean baseline body weight of 74.7 kg.

In the Phase 3a trial, Xultophy demonstrated a statistically significant and clinically meaningful superiority of Xultophy compared to Tresiba therapy. Novo Nordisk has plans to submit an NDA (New Drug Application) to Japanese regulatory authorities for marketing approval of Xultophy in the second half of 2018.

In December 2017, Novo Nordisk reported the outcomes of the quality-of-life questionnaires of the DUAL VII clinical trial. The quality-of-life questionnaire’s results concluded that once-daily Xultophy was a better treatment option for the control of diabetes compared to multiple daily insulin injections or a basal-bolus regimen.

Among the individuals who completed the quality-of-life questionnaires of the DUAL VII clinical trial, more patients preferred Xultophy therapy compared to the basal-bolus regimen.

The patient-reported outcomes of the DUAL VII trial demonstrated that patients on Xultophy had the highest improvement in the TRIM-D (Treatment-Related Impact Measure-Diabetes) score compared to Tresiba. Xultophy showed a TRIM-D score of 16.7 compared to 6.8 for Tresiba.

The label expansion of Xultophy is expected to boost revenue growth for the drug. In the marketplace, Xultophy’s peers include Eli Lilly’s (LLY) Basaglar and Sanofi’s (SNY) Toujeo and Lantus.

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