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NICE reverses negative guidance for Forxiga in diabetes

Final draft guidance backs the use of BMS/AstraZeneca’s SGLT-2 inhibitor in certain patients

NICE reverses negative guidance on Forxiga in diabetes

The UK's National Institute for Health and Care Excellence (NICE) has recommended the use of Forxiga (dapagliflozin) to treat patients with type 2 diabetes, overturning previous draft guidance that said the drug was not a cost-effective use of NHS resources.

The organisation, which appraises medicines for NHS use, said earlier this year that the drug's manufacturers – Bristol Myers Squibb (BMS) and AstraZeneca (AZ) – had not provided sufficient information to adequately assess the drug, but this issue now seems to have been addressed in final draft guidance released today.

However, the NICE recommendation limits the use of the once-daily drug, which is recommended by the European Medicines Agency (EMA) for use on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot tolerate metformin.

Instead, NICE has recommended that Forxiga only be used as part of a combination therapy alongside metformin or insulin, and with or without other oral antidiabetic drugs.

Furthermore, the metformin recommendation only covers the use of Forxiga in patients who are unable to take sulphonylurea medicines or who are at significant risk of hypoglycaemia. When combined with metformin, Forxiga may also be used instead of thiazolidinedione if weight gain is a concern.

These recommendations are based on Forxiga's method of action as a sodium glucose co transporter 2 (SGLT-2) inhibitor, which works by blocking the reabsorption of glucose in the kidneys and promoting the excretion of excess glucose in the urine.

By treating diabetes in this manner, SGLT-2 inhibitors operate independently of insulin, and therefore do not carry as great a risk of hypoglycaemia or weight gain.

Despite the limitations imposed by NICE, BMS and AZ gave signs they were confident of the drug's success in the UK, saying in a statement that more than one million patients with type 2 diabetes in the UK are on either metformin alone or insulin.

Amadou Diarra, European VP and general manager UK and Ireland at BMS, said the guidance marked an “important milestone” in diabetes treatment.

“With the incidence of diabetes continuing to increase it is important for patients to have a wider choice of options so that the treatment can be tailored to their individual needs,” he said.

Final guidance is expected to be published in June 2013, according to NICE.

30th May 2013

From: Sales



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