March 06, 2019
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Top stories in endocrinology: FDA approves expanded indication for combination insulin-GLP-1 injectable, accepts request for CV safety data inclusion for obesity drug

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Among the top stories in endocrinology last week were the FDA’s approval of an expanded label indication for a fixed-ratio combination of insulin glargine and lixisenatide and its acceptance of a supplemental new drug application requesting a label update for the serotonin receptor agonist lorcaserin to include new cardiovascular safety data.

Other highlights included a study that found intensifying drug therapies did not help most adults with type 2 diabetes attain HbA1c goals, a Q&A focusing on the findings from three recent omega-3 studies and a study that suggested attempting to lose weight with the help of a smartphone-based behavioral program may be just as effective as more intensive group-based therapies for adults with obesity.

FDA approves expanded indication for combination insulin, GLP-1 injectable

The FDA approved an expanded label indication for a fixed-ratio combination of insulin glargine and lixisenatide for the treatment of patients with type 2 diabetes that is poorly controlled with oral antidiabetes therapy, Sanofi announced in a press release. Read more.

FDA accepts request for CV safety data inclusion for obesity drug

The FDA accepted a supplemental new drug application requesting a label update for the serotonin receptor agonist lorcaserin to include new cardiovascular safety data, according to a press release from Eisai. Read more.

‘Intensification inertia’ potentially hinders HbA1c goal attainment

Intensifying drug therapies did not help most adults with type 2 diabetes attain HbA1c goals, but the best results were seen with the addition of a GLP-1 receptor agonist, according to findings published in Diabetic Medicine. Read more.

Expert offers insight on recent omega-3 trials, ideal candidates

New data from three recent large-scale trials assessing omega-3 supplementation have demonstrated mixed findings for different groups of patients, suggesting a cardiovascular benefit for some high-risk individuals assigned a prescription-grade agent and likely no benefit for a primary prevention population. Read more.

Smartphone-based weight-loss program appears as effective as group intervention

Attempting to lose weight with the help of a smartphone-based behavioral program may be just as effective as more intensive group-based therapies for adults with obesity, according to findings published in Obesity. Read more.