EMA validates authorisation of Lefamulin for community-acquired pneumonia treatment

European Medicines Agency validates authorisation of Lefamulin for community-acquired pneumonia treatment.

The marketing authorization application (MAA) for the oral and intravenous (IV) formulations of lefamulin is now valid, as announced by drug maker Nabriva Therapeutics of Dublin. The authorization was determined by the European Medicines Agency (EMA). The validation allows the European Medicines Agency Committee for Medicinal Products for Human Use to begin the formal review process for lefamulin. And if approved, the drug would receive marketing authorization in all 28 European Union member states, as well as in Iceland, Norway, and Lichtenstein. An opinion is expected within the next 12 to 15 months.

Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic for treating community-acquired bacterial pneumonia (CABP) in adults.

"We are grateful for the EMA's quick validation of our MAA submission and look forward to working with the European Medicines Agency during the MAA review process. We are committed to providing European patients with CAP the potential option of short-course treatment with IV or oral lefamulin," Nabriva Chief Medical Officer Jennifer Schranz, MD, said in a company press release.

Two phase 3 clinical trials demonstrated that lefamulin was non-inferior to moxifloxacin for the treatment of adults with CAP, and was well-tolerated, the company said.

Nabriva also has New Drug Applications (NDAs) for oral and IV lefamulin currently under review by the US Food and Drug Administration (FDA). The FDA is expected to complete its fast-tracked review by Aug 19.

About CAP

CAP relates to pneumonia (any of several lung diseases) in an individual with low health care contact. It is one of the most common infectious diseases and is an important cause of mortality and morbidity worldwide. Typical bacterial pathogens that cause CAP include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.

About Lefamulin

Lefamulin is a semi-synthetic pleuromutilin antibiotic with potential to be first-in-class for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Based on results from its two global, Phase 3 clinical trials, Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line monotherapy for the treatment of CAP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile.