Azilsartan Medoxomil (1) – Edarbi®
Arterial hypertension
Characteristics
| Start date | 15.01.2012 – Marketing authorisation: 07.12.2011 |
|---|---|
| Resolution | 15.03.2012 |
| INN | Azilsartan Medoxomil |
| Brand name | Edarbi® |
| Pharm. company |
Dossier: Takeda Pharma GmbH
New distributor: TAKEDA GmbH |
| G-BA Procedure ID | D-028 |
| ATC code | C09CA09 Angiotensin II receptor blockers (ARBs), plain (C09CA) |
| ICD-10 codes (AIS) | I10.00, I10.01, I10.10, I10.11, I10.90 |
| Alpha-ID codes (AIS) | I16690Hypertension, I26736Malignant hypertension, I26740Benign hypertension, I86821Malignant hypertension with hypertensive crisis, I98156Benign essential hypertension with hypertensive crisis |
| DDD | 40 mg O |
| Therapeutic area | Cardiovascular diseases Hypertension (Arterial hypertension / Essential hypertension) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Edarbi is indicated for the treatment of essential hypertension in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with essential hypertension |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
Angiotensin II antagonists, Group 1, in Stage 2
- The pharmaceutical manufacturer has not claimed any therapeutic improvement or pharmacological-therapeutic non-comparability, including on the grounds of minor side effects.
- No superior efficacy of therapeutic significance has been reliably and significantly demonstrated for the active ingredient to be classified, azilsartan medoxomil (as potassium salt) over the other active ingredients (INN) in the fixed-amount group, which is significant and clinically relevant for the therapy, has been reliably proven by means of directly comparative, randomised clinical trials with patient-relevant endpoints.
- The ‘Medicinal Products’ Sub-Committee has concluded its deliberations on determining the additional benefit of azilsartan medoxomil (as potassium salt) and on updating the fixed-amount group ‘Angiotensin II antagonists, Group 1’ in Stage 2. It has concluded that the additional benefit of azilsartan medoxomil (as potassium salt) is deemed not proven in accordance with Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V).
Courtesy translation only, please refer to the German original.
Associated procedures
| Azilsartan Medoxomil (1) | Edarbi® | Takeda Pharma GmbH | Arterial hypertension | n.d. | 100% additional benefit not proven |
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