Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

sections

Medicines licensing

EMA approves combination treatment for type 2 diabetes

Fixed-dose saxagliptin/dapagliflozin combination lowers blood glucose levels in type 2 diabetes

A new combination therapy that can lower blood glucose levels in patients with type 2 diabetes is being recommended for marketing approval for some patients by the European Medicines Agency (EMA).

If the marketing authorisation goes ahead, Qtern (AstraZeneca), a fixed-dose combination of saxagliptin and dapagliflozin, will be the first treatment of its kind to be approved in Europe, the company says.

Saxagliptin is a dipeptidyl peptidase 4 inhibitor (DPP4-1) and works by reducing the cleavage and inactivation of the incretin hormone glucagon-like peptide 1. The drug increases incretin levels, which in turn stimulate glucose-dependent insulin secretion and inhibits the release of glucagon.

Dapagliflozin is an orally active inhibitor of the human sodium-glucose co-transporter 2 (SGLT2); it reduces renal glucose re-absorption leading to urinary glucose excretion.

The new combination therapy is being recommended to improve glycaemic control in type 2 diabetes patients only when metformin and/or sulphonylurea and one of the monocomponents of saxagliptin/dapagliflozin do not provide adequate glycaemic control. It is also being recommended for patients already being treated with the free combination of dapagliflozin and saxagliptin.

Patient charity Diabetes UK welcomes the approval. Dan Howarth, its head of care, says: “One of the many burdens people with type 2 diabetes face is the plethora of medications, not just for diabetes, [but] for a wide range of health needs. If someone is already taking saxagliptin and dapagliflozin, then as long as it safe to do so, a combination medication would be of benefit.

“Both DPP4-I and SGLT2 therapy has much evidence to support its use, both with minimal side effects,” he adds. “Having further options for people to successfully manage their type 2 diabetes is something that Diabetes UK supports.”

The recommendation to grant a marketing authorisation for the product follows a positive opinion by the EMA’s Committee for Medicinal Products for Human Use on 26 May 2016. The recommendation will now go to the European Commission for approval.

In October 2015, the US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, refused a marketing authorisation for the same product.

The drug company confirmed at the time that, on the drug’s refusal, the FDA had asked it for additional clinical data. “This includes clinical trial data from ongoing or completed studies and may require information from new studies.”

Last year, AstraZeneca said it would work closely with the FDA to determine the next steps for the new drug application.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201240

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and British National Formulary for Children

    BNF and British National Formulary for Children

    Now available as a 2 year print subscription to both the BNF and British National Formulary for Children, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Pathology and Therapeutics for Pharmacists

    Pathology and Therapeutics for Pharmacists

    An practical, integrated approach to the pathophysiological and pharmacotherapeutic principles underlying the treatment of disease.

    £54.00Buy now
  • Sampson's Textbook of Radiopharmacy

    Sampson's Textbook of Radiopharmacy

    This well-established textbook provides specialised information on the use of radiopharmaceuticals in the detection and treatment of diseases.

    £81.00Buy now
  • Biological Therapeutics

    Biological Therapeutics

    An introduction to the treatment of disease using biological medicines derived from living plant and animal tissues.

    £33.00Buy now
  • Pharmacy Registration Assessment Questions 2

    Pharmacy Registration Assessment Questions 2

    Pharmacy Registration Assessment Questions 2 features more than 400 entirely new, closed book and calculation questions. It can be used in conjunction with the previous volume or on its own. All questions are in line with current GPhC guidance, enabling you to prepare for the pharmaceutical pre-registration exam with confidence.

    £35.00Buy now
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • European Medicines Agency

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.