Nabriva publication of Phase 3 clinical trial results highlights efficacy of XENLETA™ (lefamulin tablets) as novel, short-course, empiric monotherapy for adults with community-acquired bacterial pneumonia (CABP)
September 27, 2019 at 12:15 PM EDT
DUBLIN, Ireland, Sept. 27, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the Journal of the American Medical Association (JAMA) has published results from the company’s Lefamulin Evaluation Against Pneumonia 2 (LEAP 2) clinical trial. The U.S. Food and Drug Administration (FDA) approved lefamulin on August 19, 2019 under the brand name XENLETA™, which is now available for the treatment of adults with CABP. XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades.
“The increasing prevalence of antimicrobial resistance in the most common causative pathogens of CABP, along with growing evidence of safety concerns with fluoroquinolones makes a compelling case for the development of new antibacterial classes with novel mechanisms of action (MOA) to treat patients with CABP,” said Jennifer Schranz, MD, Chief Medical Officer of Nabriva Therapeutics. “Xenleta is the first novel MOA antibiotic approved in the United States in nearly 20 years. The results from the LEAP clinical trial program, combined with lefamulin’s targeted spectrum of activity, which aligns with the principles of antimicrobial stewardship, make it an attractive short-course, monotherapy treatment option for adults with CABP.”
The publication, entitled “Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults with Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial,” is available online.
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