The European Commission (EC) Issues a Legal Binding Decision for the Approval of XENLETA from Nabriva Therapeutics PLC – ADR (NASDAQ:NBRV)

XENLETA (lefamulin) from Nabriva Therapeutics PLC – ADR (NASDAQ:NBRV) has received a legal and binding approval of the marketing authorization application from the European Commission (EC). The European Medicines Agency (EMA) says that it is confident about using the semi-synthetic pleuromutilin antibiotic in the treatment of community-acquired pneumonia (CAP) in adults.

The approval follows a previous one in August 2019, whereby XENLETA was approved as a treatment for community-acquired bacterial pneumonia (CABP). Its novel mechanism of action is believed to have the ability to fight against CAP’s most common pathogens.

The Marketing Authorization Is an Important Step Forward For Patients with CAP

Statistics indicate that the European Union record increased cases of pneumonia every year. However, morbidity and mortality cases associated with community-acquired pneumonia are more common in older patients. A study carried out in 2015 by the Global Burden of Disease revealed that lower respiratory tract infections claimed three million lives annually.

Nonetheless, EMA’s approval of XENLETA is an indicator that it is a non-inferior to the current standard-of-care from moxifloxacin Thus, according to the CEO of Nabriva Therapeutics, Ted Schroeder, and the marketing authorization is a big step in giving patients with CAP options of treatment.

‘’We believe the approval of XENLETA is a significant advancement in the fight against antimicrobial resistance and we are excited to bring this critically needed medicine to patients throughout Europe,” Schroeder emphasized.

The Declining Effectiveness of Antibiotics 

In recent years, there has been a growing resistance and cross-resistance in the use of antibiotics. This has put the healthcare providers at a spot not to offer appropriate healthcare to those suffering from serious infections. More often than not, they have resulted in using antibiotics, which again have become toxic to a majority of patients.

However, Nabriva says it is committed to addressing this urgent need through enhanced development and research efforts. The company has identified several candidates, which, if approved, will be options of treating uncomplicated skin and skin structure infections. This will be accomplished through engaging industry experts who share in the company’s passion.