UK launch for Novo's new diabetes pill

Novo Nordisk has launched in the UK the first 'protein in a pill' treatment for type II diabetes.

Rybelsus (semaglutide tablets) is the world’s first and only oral GLP-1 receptor agonist (RA), which physicians in the UK, including GPs, can now prescribe for adults with insufficiently controlled type II diabetes to improve glycaemic control.

Despite a number of treatments on the market, 40% of adults with the disease in the UK fail to achieve target blood sugar of ≤7%, increasing the risk of diabetes-related complications and underscoring the need for new strategies.

In the PIONEER clinical development programme, Rybelsus showed significantly greater HbA1c reduction at one year, with the additional benefit of consistent weight reduction, versus treatments used in the UK: sitagliptin, empagliflozin and liraglutide, Novo noted.

Also, up to seven out of 10 patients achieved target blood sugar (HbA1c) of <53 mmol/mol (7%) with oral semaglutide.

It is hoped that the availability of an oral GLP-1 RA – which, as protein-based treatments, were until now only deliverable by injection – might improve patient adherence to this class of medicines.

Also, Rybelsus prescriptions can be initiated remotely, which is a particular advantage during the pandemic given that diabetes increases the risk of death from coronavirus, Novo highlighted.

“GLP-1 RAs are recognised as offering glycaemic control and weight loss benefits compared to other types of type II diabetes treatment, but are clinically underutilised because they are only available as injectables,” said Professor Steve Bain, Professor of Medicine (Diabetes) at Swansea University Medical School.

“Being able to offer patients the option of a GLP-1 RA in-a-pill may make it easier for physicians, including GPs, to intensify treatment earlier for people with type II diabetes who are not controlled on their current treatment, helping them achieve their clinical treatment goals and reduce their risk of serious complications.”

The Danish drugmaker confirmed that oral semaglutide is priced “at parity with other GLP-1 RAs in the UK”, and it noted that the cost-effectiveness of GLP-1 RAs has already been determined in national guidelines including The National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC).

As such, NICE will not be carrying out a single technology appraisal (STA) for oral semaglutide, and so Novo said it will work with the NHS to ensure that physicians, including GPs, in England and Wales can secure access for their patients.

Oral semaglutide will also be reviewed as part of the NICE guidelines update for type II diabetes, and a decision is expected from the Scottish Medicine Consortium (SMC) later in 2020.