Novo Nordisk’s SC semaglutide for diabetes maintains good approval chances despite retinopathy concerns, additional pre-approval studies warranted – experts

23 Sep 2016

Novo Nordisk’s (CPH:NOVO-B) subcutaneous (SC) semaglutide has sound future approval projections in diabetes despite demonstrating significant diabetic retinopathy in its Phase III SUSTAIN 6 trial, experts said.

SUSTAIN 6’s encouraging cardiovascular (CV) benefit outcomes likely outweigh retinopathy concerns, which will most likely require a label warning and further monitoring. Some experts argued retinopathy can be avoided by slow dose titration and prior screening, while most cases in the trial suffered a pre-existing baseline retinopathy risk.

Nonetheless, certain experts added longer, larger premarket trials assessing both retinopathy and CV superiority will boost approval forecasts.

SUSTAIN 6 results were released at last week’s EASD conference in Munich, demonstrating trial success with 6.6% of semaglutide patients achieving the primary endpoint – time from randomisation to first occurrence of a major CV event defined as non-fatal MI or stroke up to 148 weeks – versus placebo’s 8.9% (p

SUSTAIN 6’s significant retinopathy complication incidence was unexpected, despite occurring insignificantly in Novo’s 9,340-patient Phase III LEADER trial of now marketed Victoza (liraglutide), said Dr Steve Bain, SUSTAIN 6 investigator and professor of medicine, Swansea University Medical School, UK. Nonetheless, semaglutide’s potential CV benefit likely outweighs the complication risk, maintaining its future approval prospects with likely retinopathy labelling, three experts agreed. A black box warning will likely be given, however, considering diabetes is a leading cause of vision loss, such a warning should theoretically be applied to all diabetes therapies, said Dr Zachary Bloomgarden, clinical professor, Mount Sinai School of Medicine, New York.

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