Bagsværd, Denmark, 20 September 2019 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Rybelsus® (semaglutide tablets), as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Rybelsus®, the brand name for oral semaglutide in the US, is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet. The approval of Rybelsus® is based on the results from 10 PIONEER clinical trials which included 9,543 adults with type 2 diabetes. Rybelsus® more effectively lowered blood sugar than sitagliptin and empagliflozin. Furthermore, treatment with Rybelsus® resulted in up to 4.4 kg reduction in body weight. Rybelsus® demonstrated a safe and well-tolerated profile across the PIONEER programme, with the most common adverse event being mild to moderate nausea which diminished over time.
“We are very excited that we can make the first oral GLP-1 available in the US and thereby expand the treatment options for adults living with type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Novo Nordisk has a very long legacy of developing innovative injectable medicines for people living with diabetes and, with the approval of Rybelsus®, we are now able to bring our innovation into the market for oral antidiabetics.”
Novo Nordisk plans to make Rybelsus® available to adults with type 2 diabetes in the US in the fourth quarter of 2019.
A new international TALK-HYPO study, which surveyed 4,300 family members of people living with diabetes, shows that 64% of family members of people with diabetes are worried or anxious about the risk of hypoglycaemia, and that more open conversations may help.
66% state that they think about their family members’ risk of hypos at least once a month, 74% of the study participants that were helping their relative with diabetes to manage their hypos state that they spend less time on, or forgo entirely, other activities such as hobbies, holidays or being with other friends or family as a result.
What if medicines injected by millions could be delivered in tablets?
After almost 100 years of delivering injectable therapies, Novo
Nordisk’s R&D team is finding answers to this enduring question.
Chief Science Officer Mads Krogsgaard Thomsen is leading the way and
he reflects on the magnitude of the scientific challenge and the
progress made in his laboratories.
Novo Nordisk intends to achieve the target to use only renewable electricity in
its global production facilities by 2020. The announcement on 30
April followed a new investment in a 672-acre solar panel
installation, roughly the size of 500 football fields, in North
Carolina, US, which will provide power to Novo Nordisk’s entire US
operations from early 2020. Novo Nordisk is the first pharmaceutical
to use only renewable electricity
in production. RE100 is a collaborative, global initiative of
businesses committed to using 100% renewable electricity.
Read more about Circular
for Zero and download
the full press release on the environmental ambitions
When Becky Furuta was told her cycling career was over due to her
diabetes, she defied doctors' orders to rise to the top of her
The International Committee of the Red Cross (ICRC), the Danish Red
Cross (DRC) and Novo Nordisk have partnered to tackle the growing
issue of chronic diseases that affect millions of people living in
humanitarian crises around the world. Focus will be on ensuring
efficient supply of low-cost human insulin in vials to Red Cross
globally; support for ICRC’s and DRC’s health programmes; 2-3 projects
to provide care to people with hypertension and diabetes in
humanitarian crises to be conducted within three years.
When Pâris was diagnosed with type 1 diabetes at the age of two, his mother Wendy began filming. She didn’t stop for 16 years.
1 November - third quarter
The Danish Government and Novo Nordisk have announced grants of 3 and 5 million US dollars respectively to the Defeat-NCD Partnership. The aim is to raise 100 million dollars to fund mobilisation of knowledge, tools, capacities and finances to scale-up action to defeat NCDs in low-resource countries.