Ebymect
Metabolic· 33 cited findings· 1 source document
Company: AstraZeneca PLC →
What the regulatory reviews say
Ebymect is a drug for which a Marketing Authorisation application was submitted on 3 July 2015, following eligibility to the centralised procedure being agreed on 26 February 2015. The legal basis for this application was Article 10(c) of Directive 2001/83/EC. The procedure started on 27 July 2015, and a CHMP positive opinion for Marketing Authorisation was issued on 24 September 2015. A Community Marketing Authorisation for Xigduo, a related product, was granted on 16 January 2014.
Safety data indicate varying rates of hypoglycaemia. The minor hypoglycaemia rate with dapagliflozin 10 mg + metformin was 6.9%, compared to 5.5% with placebo + metformin. When dapagliflozin 10 mg was combined with insulin, the minor hypoglycaemia rate was 40.3% at Week 24 and 53.1% at Week 104. For major hypoglycaemia with dapagliflozin 10 mg + insulin, the rate was 0.5% at Week 24 and 1.0% at Week 104. A creatinine clearance threshold of < 60 ml/min and an eGFR threshold of < 60 ml/min/1.73 m2 are contraindications for the drug.
Key figures — cited to the source page
| Minor hypoglycaemia rate with dapagliflozin 10 mg + metformin | 6.9 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.15 |
| Minor hypoglycaemia rate with placebo + metformin | 5.5 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.15 |
| Minor hypoglycaemia rate with dapagliflozin 10 mg + insulin at Week 104 | 53.1 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.16 |
| Major hypoglycaemia rate with dapagliflozin 10 mg + insulin at Week 104 | 1.0 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.16 |
| Marketing Authorisation application submission date | 3 July 2015 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.3 |
| CHMP positive opinion date for Marketing Authorisation | 24 September 2015 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.4 |
| Creatinine clearance threshold for contraindication | < 60 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.20 |
| eGFR threshold for contraindication | < 60 | AstraZeneca PLC — Ebymect EMA EPAR public assessment report, p.20 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.