JDRF International voices disappointment as drug for type 1 diabetes is withdrawn by AstraZeneca
The leading global type 1 diabetes charity, JDRF international, expresses its disappointment with the removal of a drug from the UK and European marketplace that can help people living with type 1 diabetes stay healthy.
AstraZeneca last week notified clinicians that the drug dapagliflozin, also known by its brand name Forxiga, would be immediately withdrawn in the UK and EU, potentially affecting more than 2,000 people in the market with type 1 diabetes, despite AstraZeneca citing no new safety issues with the drug.
JDRF International is now calling upon AstraZeneca to explain to people affected by type 1 diabetes why the drug has been withdrawn.
Dapagliflozin is the only other drug besides insulin that has been licensed in the European market to treat type 1 diabetes and is a major advancement since the discovery of insulin 100 years ago. Dapagliflozin was approved for use as an adjunct to insulin in those with T1D by the European Commission in March 2019.
The first of its kind to be licensed for treatment of adults with type 1 diabetes, dapagliflozin is a once-a-day pill which, when used alongside standard insulin therapy, significantly improves blood sugar control for many people with the life-threatening condition. Managing type 1 diabetes with insulin alone is challenging and intensive, leaving a significant physical and mental burden upon the individual.
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 hypoglycemic 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 It is appalling that it is now being withdrawn, even though many people with type 1 are finding it an effective and useful tool to help manage their glucose levels. JDRF asks AstraZeneca to explain to people affected by type 1 diabetes the reasons behind this withdrawal.”
Sanjoy Dutta, JDRF International Vice President of Research, said “For many individuals across the globe who have followed the positive results of dapagliflozin in treating type 1 diabetes and the potential for it to become available in their country, this is devastating news. The impending negative impact of removing a drug like dapagliflozin from any market can be detrimental in the potential for other national medical ruling boards to have confidence in approving it for their citizens. We stand with our type 1 diabetes communities across the globe in demanding an explanation to clarify this removal.”