Questions & Answers
On 19 April 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Forxiga, 5 mg, 10 mg, film-coated tablet intended for the treatment of type 2 diabetes mellitus in adults.
The applicant for this medicinal product is Bristol-Myers Squibb/AstraZeneca EEIG. It may request a re-examination of any CHMP opinion, provided it notifies the European Medicines Agency in writing of its intention within 15 days of receipt of the opinion.
The active substance in Forxiga is dapagliflozin - drugs used in diabetes, other blood glucose lowering drugs, excluding insulins (A10BX09). Forxiga is a competitive, reversible, selective and orally active inhibitor of the human sodium-glucose co-transporter 2 (SGLT2), which reduces renal glucose re-absorption leading to urinary glucose excretion.
The benefits with Forxiga are its ability to lower blood glucose by increasing urinary glucose excretion. The most common side effects are hypoglycaemia (when used with a sulphonylurea or insulin), urinary tract infection, genital tract infection, dyslipidaemia, dysuria and polyuria. Specific safety issues regarding a tumour imbalance in dapagliflozin-treated patients, the limited data available in patients more than 75 years old, and the use in patients at risk of volume depletion, hypotension and electrolyte imbalances have been evaluated and addressed in the summary of product characteristics (SmPC) and in the risk management plan.
A pharmacovigilance plan for Forxiga will be implemented as part of the marketing authorisation.
The approved indication is:
Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Detailed recommendations for the use of this product will be described in the SmPC, which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit to risk balance for Forxiga and therefore recommends the granting of the marketing authorisation.
|Name||Language||First published||Last updated|
|CHMP summary of positive opinion for Forxiga||(English only)||2012-04-20|
|INN or common name|
|Therapeutic area||Diabetes Mellitus, Type 2|
dapagliflozin propanediol monohydrate
|Date opinion adopted||19/04/2012|
Bristol-Myers Squibb / AstraZeneca EEIG
|Application type||Initial authorisation|