Forxiga

dapagliflozin

Table of contents

Opinion

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Forxiga. The marketing authorisation holder for this medicinal products is AstraZeneca AB.

The CHMP adopted a new indication as follows:

Heart failure

Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

For information, the full indications for Forxiga will be as follows1:

Type 2 diabetes mellitus

Forxiga is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance.
  • in addition to other medicinal products for the treatment of type 2 diabetes.

For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Type 1 diabetes mellitus

Forxiga is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

Heart failure

Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Forxiga
Agency product number
EMEA/H/C/002322
International non-proprietary name (INN) or common name
  • dapagliflozin
Active substance
  • dapagliflozin propanediol monohydrate
Therapeutic area
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Date opinion adopted
15/10/2020
Company name
AstraZeneca AB
Status
Positive
Application type
Post-authorisation

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