Pitavastatin (1) – Livazo®

• Clinical trials
  • The pharmaceutical manufacturer has not demonstrated, in a reliable, statistically significant and clinically relevant manner, that the active ingredient to be classified, pitavastatin, is superior in efficacy—in a way that is clinically significant for the treatment—to the other active ingredients in the fixed-amount group, through directly comparative, randomised, clinical trials with patient-relevant endpoints.

HMG-CoA reductase inhibitors, Group 1, in Tier 2

• The legal consequence of the company’s decision to refrain from submitting a dossier at the relevant time is the determination that the additional benefit is not proven.
• The pharmaceutical manufacturer has not claimed any therapeutic improvement or pharmacological-therapeutic non-comparability, including on the grounds of minor side effects.
• The ‘Medicinal Products’ Sub-Committee has concluded that the additional benefit of pitavastatin pursuant to Section 35a(1), fifth sentence, of SGB V is deemed not proven, the conditions under Section 35a(4), first sentence, of SGB V are met and, consequently, pitavastatin is to be classified in the fixed-amount group ‘HMG-CoA reductase inhibitors, Group 1’ in Tier 2 pursuant to Section 35a(4), first sentence, in conjunction with Section 35(1), second sentence, No. 2 of the SGB V (fixed-amount grouping).

Courtesy translation only, please refer to the German original.