Azilsartan Medoxomil (1) – Edarbi®

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.