Nabriva Therapeutics plc (NASDAQ:NBRV) has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has approved a positive view for the XENLETA’s (lefamulin) approval in treating adults with pneumonia acquired outside hospital (CAP).
Nabriva expects a decision on Approval of XENLETA in the second half of 2020
XENLETA is being approved for the treatment of CAP where using antibacterial agents has proved to be inappropriate as the initial CAP treatment or where they have been unsuccessful. The European Commission will review the CHMP opinion since it has the mandate of approving medicines in the EU countries including Iceland, Liechtenstein, and Norway. The company expects a regulatory verdict from the commission in the 2H of this year.
Jennifer Schranz the CEO of Nabriva indicated that the announcement of the CHMP opinion takes the company closer to the approval of XENLETA. This will be the first authorization in almost 20 years of a new first-in-class antibiotic for CAP patients in Europe. Jennifer indicated that drug has a proprietary action mechanism and it offers the urgently required short course and empiric monotherapy CAP treatment option for adults. She added that they are looking forward to EU’s decision.
Trials indicate XENLETA was well tolerated in CAP patients
The positive opinion of the CHMP for marketing approval is centred on Lefamulin Evaluation Against Pneumonia 1 as well as LEAP 2 efficacy studies. The efficacy data were from a database of around 1,242 trial participants.
In another two-third phase studies, the co-primary endpoint of EMA was the Investigator Assessment of Clinical Response at Test of Cure in intent-to-treat (mITT) and clinically evaluable (CE) populations. Results from both trials indicated that XENLETA was non-inferior compared to independent treatment of CAP patients through standard of care moxifloxacin. This was also consistent following the analysis of pooled data from PORT scores of II to V. The pooled data analysis showed IACR attainment frequency at Test of Cure in the mITT population to be 85% for XENLETA while it was 87.1% in moxifloxacin. However, XENLETA was well tolerated in the trials.