JDRF calls for AstraZeneca to explain type 1 diabetes drug withdrawal

AstraZeneca last week alerted clinicians that the drug dapagliflozin, also known by its brand name Forxiga, would be withdrawn immediately for type 1 diabetes use in the UK and EU.

The decision could affect up to 2,000 people in the UK with type 1 diabetes, even though, according to AstraZeneca, there are no new safety issues with the drug.

Clear explanation for withdrawal needed

JDRF is now calling on AstraZeneca to clearly explain to people affected by type 1 diabetes why the drug has been withdrawn for use treating that condition. The drug will continue to be available for other conditions including type 2 diabetes.

Dapagliflozin is a once-a-day pill which, when used alongside standard insulin therapy, significantly improves blood glucose management for many people with the life-threatening condition.

The first of its kind to be approved in the UK and EU for adults with type 1 diabetes, it is the only other drug besides insulin that has been licensed in the UK to treat type 1 diabetes.

Huge advancement in type 1 treatment

Its development was one of the biggest advancements in the treatment of type 1 diabetes since the discovery of insulin 100 years ago.

JDRF has long advocated for therapies that can improve the lives of those affected by type 1 diabetes, including treatments such as dapagliflozin. It was made available on the NHS as an ‘adjunct therapy’ to be used alongside insulin for people with type 1 diabetes by NICE in July 2019.

Managing type 1 diabetes with insulin alone is challenging and intensive, leaving a significant physical and mental burden upon the individual. Currently, just 30 per cent of people with type 1 diabetes reach their recommended blood glucose targets, putting them at greater risk of health complications.

Lower HbA1c levels

Dapagliflozin helps to reduce blood glucose levels by stopping the kidneys from reabsorbing glucose into the body. Instead, excess glucose is passed out in urine. Previous clinical trials showed that, when used alongside insulin, the drug helped people lower their HbA1c levels (a measure of average blood glucose levels) without increasing the incidence of hypoglycaemic events. Keeping HbA1c levels as close to the recommended target of 6.5% as possible is important in preventing long-term type 1 diabetes complications.

Karen Addington, UK Chief Executive of JDRF, said: “Dapagliflozin has been the first drug offered in 100 years since the discovery of insulin that has helped people with type 1 diabetes to manage their condition. It is appalling that it is now being withdrawn, even though many people with type 1 are finding it an effective and useful tool to help manage their glucose levels. Breakthrough T1D UK asks AstraZeneca to explain to people in the UK affected by type 1 diabetes the reasons behind this withdrawal.”

Anyone affected by the withdrawal of dapagliflozin should contact their healthcare professional.