Discontinuation ‘not due to safety concerns,’ says AZ
The announcement to discontinue dapagliflozin for the indication of type 1 diabetes in certain adults just two and a half years after its approval in the EU comes as a big surprise, especially as it was made with little fanfare just last month.
In the U.K., AstraZeneca sent a letter to health care professionals on Nov. 2 stating that, from Oct. 25, dapagliflozin 5 mg was “no longer authorized” for the treatment of type 1 diabetes and “should no longer be used” in this patient population.
However, it underlined that other indications for dapagliflozin 5 mg and 10 mg were “not affected by this licensing change,” and it remains available for adults with type 2 diabetes, as well as for the management of symptomatic chronic heart feature with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD).
In the letter, sent by Tom Keith-Roach, country president of AstraZeneca UK, the company asserts that the removal of the type 1 diabetes indication from dapagliflozin is “not due to any safety concern” with the drug “in any indication, including type 1 diabetes.”
It nevertheless goes on to highlight that DKA is a known common side effect of dapagliflozin in type 1 diabetes and, following the announcement, “additional risk minimization measures ... will no longer be available.”
In a separate statement, AstraZeneca said that the decision to remove the indication was made “voluntarily” and had been “agreed” with the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the equivalent body in Northern Ireland.
“It follows discussions regarding product information changes needed post-approval for dapagliflozin 5 mg specific to type 1 diabetes,” the company said, “which might cause confusion” among physicians treating patients with type 2 diabetes, chronic heart feature with reduced ejection fraction, or CKD.
AstraZeneca told this news organization that similar communications about the withdrawal were issued to health care agencies and health care professionals in all countries of the EU.
‘Appalling, devastating, disappointing’ for patients
The announcement has been met with disappointment in some quarters and outrage in others, and questions have been raised as to the explanation given by AstraZeneca for the drug’s withdrawal.
“Although only a small number of people with type 1 diabetes have been using dapagliflozin, we know that those who have been using it will have been benefitting from tighter control of their condition,” Simon O’Neill, director of health intelligence and professional liaison at Diabetes UK, told this news organization.
“It’s disappointing that these people will now need to go back to the drawing board and will have to work with their clinical team to find other ways of better managing their condition.”
Mr. O’Neill said it was “disappointing that AstraZeneca and the MHRA were unable to find a workable solution to allow people living with type 1 diabetes to continue using the drug safely without leading to confusion for clinicians or people living with type 2 diabetes, who also use it.”
Sanjoy Dutta, JDRF International vice president of research, added that the news is “devastating.”
“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,” he added.
“We stand with our type 1 diabetes communities across the globe in demanding an explanation to clarify this removal.”