{"id":5522,"date":"2019-08-20T13:18:19","date_gmt":"2019-08-20T17:18:19","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=5522"},"modified":"2021-04-16T14:56:12","modified_gmt":"2021-04-16T18:56:12","slug":"xenleta-bacterial-pneumonia-treatment","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/xenleta-bacterial-pneumonia-treatment\/","title":{"rendered":"FDA approves Xenleta to treat bacterial pneumonia"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Monday, the <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-antibiotic-treat-community-acquired-bacterial-pneumonia\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">U.S. Food and Drug Administration<\/span><\/a><span style=\"font-weight: 400;\"> (FDA) announced its approval of two formulations of Xenleta (lefamulin)\u2014oral and intravenous\u2014to treat community-acquired <a href=\"https:\/\/www.singlecare.com\/blog\/vaccinations-older-adults\/\">bacterial pneumonia<\/a> (CABP) in adults.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.nabriva.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Nabriva Therapeutics<\/span><\/a><span style=\"font-weight: 400;\">\u2014a biopharmaceutical company that specializes in the development of anti-infective agents that treat serious infections\u2014developed Xenleta more than 10 years ago. It\u2019s designed for two purposes:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to treat adults infected with pneumonia outside the hospital setting, and\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to combat antimicrobial resistance to drugs that are already on the market.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Meaning, Xenleta is capable of preventing nasty bacterial infections (like CAPB) from mutating and becoming resistant to treatment. This is an important breakthrough as resistant bacteria, or \u201cSuperbugs,\u201d that are invulnerable to most common antibiotics become more and more common. \u201cSuperbugs\u201d that cause pneumonia, urinary tract infections, and other infections are some of the more dangerous mutations of bacterial infections we face today.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Xenleta can potentially change that. The medication works by inhibiting the synthesis of bacterial protein, which is necessary for bacteria to be able to grow and change.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cToday\u2019s approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,\u201d Ted Schroeder, chief executive officer of Nabriva Therapeutics, said in a press conference.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Julio Ramirez, MD, professor of medicine and chief within the Division of Infectious Diseases at University of Louisville School of Medicine, added in a <\/span><a href=\"https:\/\/www.globenewswire.com\/news-release\/2019\/08\/19\/1903735\/0\/en\/Nabriva-Therapeutics-Receives-U-S-FDA-Approval-of-Xenleta-lefamulin-to-Treat-Community-Acquired-Bacteria-Pneumonia-CABP.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">press release<\/span><\/a><span style=\"font-weight: 400;\">: \u201cAs an infectious disease specialist who treats CABP patients in the hospital setting, I am grateful to have both a new IV and oral option that gives me confidence that my patients will continue to receive appropriate therapy once they are discharged from the hospital.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Pneumonia is behind 257,000 trips to the ER every year, <\/span><a href=\"https:\/\/www.cdc.gov\/nchs\/fastats\/pneumonia.htm\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">according to the Centers for Disease Control and Prevention<\/span><\/a><span style=\"font-weight: 400;\">. Additionally, it causes nearly 50,000 deaths annually. The hope is that treatments such as Xenleta can significantly drive these numbers down.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to Nabriva, Xenleta will be available through major U.S. specialty distributors by mid-September 2019. The medication will have a wholesale acquisition (WAC) price of $205 per IV patient treatment day and $275 per oral patient treatment day. Cash pay prices and the costs for patients with insurance will be determined closer to the drug\u2019s release.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Monday, the U.S. Food and Drug Administration (FDA) announced its approval of two formulations of Xenleta (lefamulin)\u2014oral and intravenous\u2014to treat community-acquired bacterial pneumonia (CABP) in adults.\u00a0 Nabriva Therapeutics\u2014a biopharmaceutical company that specializes in the development of anti-infective agents that treat serious infections\u2014developed Xenleta more than 10 years ago. It\u2019s designed for two purposes:\u00a0 to [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6925,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[4141,20795],"coauthors":[8722],"class_list":["post-5522","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-fda-approvals","tag-respiratory-illness","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bacterial pneumonia treatment \u2014 Xenleta \u2014 is FDA-approved<\/title>\n<meta name=\"description\" content=\"The FDA announced their approval of two formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.\" \/>\n<meta name=\"robots\" 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