Emisphere Announces Novo Nordisk Development Update
Novo Nordisk recently announced the European Commission (EC) has granted marketing authorization for Rybelsus, (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. The marketing authorization applies to all 27 European Union member states and the United Kingdom. Rybelsus utilizes Emisphere Technologies, Inc.’s proprietary Eligen SNAC Carrier Technology.
Rybelsus is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist. The approval is based on the results from 10 PIONEER clinical trials, in which Rybelsus after 52 weeks demonstrated statistically significant reductions in HbA1c vs sitagliptin, empagliflozin, and liraglutide and with up to 4.3-kg weight reduction. Across the PIONEER program, Rybelsus demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished over time.
“We are very excited about the approval of Rybelsus as we can now offer people in Europe living with type 2 diabetes the first and only GLP-1 in a tablet,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer. “Based on its strong clinical profile, we believe Rybelsus has the potential to set a new standard for the treatment of type 2 diabetes, as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”
The launch of Rybelsus is expected to take place in the first EU countries in the second half of 2020.
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1. Rybelsus is approved in the US, Switzerland, and EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg. Rybelsus is currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.
Emisphere is a drug delivery company that utilizes its proprietary Eligen Technology to develop new oral formulations of therapeutic agents. Emisphere is currently partners with global pharmaceutical companies for the development of new orally delivered therapeutics. For more information, visit www.emisphere.com.
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