The first glucagon-like peptide-1 (GLP-1) receptor agonist in tablet form has been approved for people with type 2 diabetes in the US.
Rybelsus, (medication name semaglutide) has been approved by the US’s official drugs body the Food and Drug Administration (FDA).
Manufactured by Novo Nordisk, the tablet is to be taken once a day as part of treatment, alongside following a healthy diet and taking regular activity. The drug will be available in dosages of 7mg and 14mg.
Semaglutide has previously been approved, under the name Ozempic, in both the US and the UK as an injectable medication.
The medication has been approved for public use after ten clinical trials were carried out involving more than 9,500 people with type 2 diabetes.
The findings showed Rybelsus to be more effective in lowering blood glucose levels when compared to other type 2 medications; sitagliptin and empagliflozin. In addition, it also helped people lose up to 4.4kg (10 lbs) in weight.
Rybelsus will carry a ‘boxed warning’ that there is a potential increased risk of thyroid c-cell tumors. Additional warnings regarding the drug relate to pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury and hypersensitivity reactions.
Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “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.
“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.”
The drug is currently being reviewed by other drug regulatory agencies in Europe and Japan for public use.
The medication is also under review by the FDA to see if it can help mitigate adverse cardiovascular effects in people with type 2 diabetes and cardiovascular disease. To date, the medication has shown promise with good results as part of the PIONEER 6 trial.
