{"id":391690,"date":"2014-04-14T00:00:00","date_gmt":"2014-04-14T00:00:00","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/report\/dbasid0114-biopharma-gram-negative-infections-due-to-multidrug-resistant-enterobacteriaceae-decision-base-us-2014\/"},"modified":"2026-04-17T23:45:42","modified_gmt":"2026-04-17T23:45:42","slug":"dbasid0114-biopharma-gram-negative-infections-due-to-multidrug-resistant-enterobacteriaceae-decision-base-us-2014","status":"publish","type":"report","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/report\/dbasid0114-biopharma-gram-negative-infections-due-to-multidrug-resistant-enterobacteriaceae-decision-base-us-2014\/","title":{"rendered":"Gram-Negative Infections Due to Multidrug-Resistant Enterobacteriaceae | Decision Base | US | 2014"},"content":{"rendered":"<p><em>As Healthcare Providers Seek to Contain Growing Costs, New Agents Will Need to Demonstrate Improvements Across Efficacy, Safety, and Delivery Attributes to Justify Premium Pricing<\/em><\/p>\n<p>The increasing prevalence and severity of infections caused by multidrug-resistant (MDR) gram-negative pathogens, particularly MDR <em>Enterobacteriaceae,<\/em> and the meager pipeline of novel antibiotic therapies in development to treat gram-negative infections (GNIs) have resulted in limited treatment options for an increasing number of patients. Government efforts are under way to promote the development of novel antibiotics to treat these infections, including the Infectious Diseases Society of America\u2019s proposed Limited Population Antibacterial Drug (LPAD) approval pathway. This regulatory pathway was submitted as part of the Antibiotic Development Plan to Advance Patient Treatment Act of 2013 (ADAPT), which was introduced into the House of Representatives in December 2013. The LPAD approval pathway and ADAPT legislation are designed to promote the prompt approval of drugs intended for diseases for which there is high unmet need. Although the regulatory environment for developing new antibiotic therapies has been challenging, the late-stage clinical pipeline for antibiotics against MDR gram-negative pathogens includes two promising cephalosporin\/beta-lactamase inhibitor combinations: Cubist\u2019s CXA-201 (ceftolozane\/tazobactam) and AstraZeneca\/Forest Laboratories\u2019 CAZ-AVI (ceftazidime\/avibactam). Other promising therapies in development include Tetraphase\u2019s IV and oral tetracycline eravacycline; Achaogen\u2019s next-generation aminoglycoside plazomicin; and Merck\u2019s Primaxin plus MK-7655 (imipenem\/cilastatin + MK-7655), a combination carbapenem\/beta-lactamase inhibitor therapy. Despite these developments, opportunities remain for more therapies that can improve clinical cure rates and reduce all-cause mortality in patients with GNIs due to MDR <em>Enterobacteriaceae.<\/em> Recent changes to FDA and EMA guidelines for antibiotic drug development now provide pathways moving forward for manufacturers developing new antibiotics to treat serious GNIs for which treatment options are limited.<\/p>\n","protected":false},"template":"","class_list":["post-391690","report","type-report","status-publish","hentry","report-gateway-biopharma","biopharma-geography-us","biopharma-date-574"],"acf":[],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/391690","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/report"}],"version-history":[{"count":1,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/391690\/revisions"}],"predecessor-version":[{"id":394813,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/391690\/revisions\/394813"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=391690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}