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First oral drug approved by EMA for use in treating type 1 diabetes

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The oral drug Forxiga (dapagliflozin) has been approved by an official European body to help treat type 1 diabetes.

Forxiga is the first drug to be approved by the European Medicines Agency for use in type 1 diabetes alongside insulin when insulin alone does not provide adequate blood glucose control.

AstraZeneca’s Forxiga drug, a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, has been given the thumbs up by the European Medicines Agency’s (EMA) advisory body, the Committee for Medicinal Products for Human Use (CHMP).

Forxiga is already approved for people with type 2 diabetes in Europe. It is a tablet medication which helps to lower blood glucose levels by helping to excrete excess glucose through urine.

The CHMP based its decision on the positive outcomes recorded from two clinical trials which examined the drug.

The DEPICT-1 (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) trial was one of the studies and showed Forxiga improved blood glucose control without increasing the risk of hypoglycemia.

The DEPICT-2 study followed and concluded the treatment was “well tolerated and improved glycemic control with no increase in hypoglycemia versus placebo but with more [diabetic ketoacidosis (DKA)] events”.

Now the results from the CHMP’s review will be passed to the European Commission, which will likely grant an extension to its licence within the coming months, meaning it could become the first oral medication for those with type 1 diabetes to use, alongside insulin.

Forxiga is also being reviewed in American and Japan by regulators.

The increase in DKA risk is one of the factors the NHS will need to consider as to whether it approves use of the drug for people with type 1 diabetes.

DKA can be a potentially fatal short-term complication and therefore the NHS will need to assess whether the benefits of the drug are high enough to outweigh the risks.



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