Therapy Areas: Diabetes
Novo Nordisk awarded FDA approval for first oral GLP-1 analog treatment Rybelsus for type 2 diabetes in adults
23 September 2019 -

Novo Nordisk reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for the once-daily Rybelsus (semaglutide) tablets in 7 mg or 14 mg for the treatment of adults with type 2 diabetes.

Rybelsus, which is taken along with diet and exercise to improve blood sugar (glucose) in type 2 diabetes patients, is the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment, added the company.

Type 2 diabetes is reportedly a global public health issue that impacts more than 28 million people in the US alone.

This US approval is based on results from the company's ten PIONEER clinical trials in 9,543 participants, which included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg. Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight, revealed the company.

Rybelsus will be launched in the US beginning in the fourth quarter of 2019. Its Initial supply will come from manufacturing facilities in Denmark; however, future its supply will come from manufacturing facilities in the US, concluded the company.

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