XERAVA (eravacycline)

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,

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.