The Committee deems that the clinical benefit of XERAVA (eravacycline) is substantial in the treatment of complicated intra-abdominal infections only in the event of infection with eravacycline-susceptible microorganisms and when the therapeutic alternatives are deemed to be inappropriate,
Insufficient
The Committee deems that the clinical benefit of XERAVA (eravacycline) is insufficient to justify public funding in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
its broad-spectrum in vitro activity against Gram-positive or negative bacteria and anaerobic bacteria, some of which are resistant to carbapenems and other antibiotics;
demonstration of the non-inferiority of eravacycline compared to ertapenem and meropenem on the percentage of clinical recoveries, in patients with non-severe complicated intra- abdominal infections;
the medical need partially met by the existence of alternatives having demonstrated an efficacy in the event of infections with multi-drug resistant bacteria;
but:
the lack of data in more severe patients or those with infections due to multi-drug resistant bacteria, who have not been included in clinical studies;
the difficulty of transposing experimental data given that the patients included in the trials are not representative of those likely to be given eravacycline in clinical practice;
the absence of comparative data versus tigecycline in patients with an infection due to multi-drug resistant bacteria, despite this comparison being possible;
the Transparency Committee deems that XERAVA (eravacycline) concentrate for solution for infusion provides no clinical added value (CAV V) in the treatment of complicated intra-abdominal infections.
Listen
