
FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form
Novo Nordisk officials believe the new therapy will fufill an unmet need for patients with type 2 diabetes and obesity who need a GLP-1 receptor agonist but do not wish to use an injectable drug.
FDA today approved oral semaglutide, to be sold as Rybelsus, the first glucagon-like peptide-1 (GLP-1) receptor agonist available in a pill form. Novo Nordisk, which previously received approval for injectable semaglutide (Ozempic), sought approval for the oral type 2 diabetes (T2D) therapy in March under a priority review process.
The filings are based on the
Oral semaglutide is approved in 2 doses, 7 mg and 14 mg, which will be available in the fourth quarter of 2019, according to a sattement from Novo Nordisk.
The drug could address an unmet need in patients with T2D who are overweight, as the GLP-1 receptor agonist class has been shown to help patients achieve significant weight loss. However, not all patients are willing to use an injectable drug, even one only needed once a week.
"People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual [glycated hemoglobin] goals," Todd Hobbs, vice president and United States chief medical officer of Novo Nordisk,
During a
Phase 3 data published in March
FDA’s decision comes a week after the Institute for Clinical and Economic Review (ICER) found in a
Oral semaglutide, the ICER authors wrote, would produce “incremental benefit” compared with other T2D treatments in terms of preventing heart attacks, strokes, and other major CV events. But, they continued, this is “only part of the treatment puzzle,” and other options may provide better treatment at a lower cost.
When contacted by The American Journal of Managed Care® a spokesperson for Novo Nordisk said the company will respond to the draft ICER report at the end of October.
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