Gram-Negative Infections due to Carbapenem-Resistant Organisms | Decision Base | US | 2015

The Alarming Scarcity of Treatment Options for These Pathogens Presents an Attractive Market Opportunity for Novel Antibiotics

The carbapenems are a class of potent gram-negative antibiotics that represent a last-line of defense for drug-resistant gram-negative infections (GNIs). However, the increasing prevalence and severity of infections caused by multidrug-resistant gram-negative pathogens, particularly carbapenem-resistant organisms (CROs), and the diminished commercial interest in developing novel antibiotics have resulted in a very limited and compromised CRO armamentarium characterized by agents with severe safety and tolerability risks. Public health officials and physicians alike are calling for immediate action and drug development to address this significant global public health concern. Pending legislation and other government-sponsored efforts, combined with an evolving regulatory landscape, are providing the framework to streamline and promote the development of novel antibiotics, including the FDA’s acceptance of nontraditional clinical development programs for investigational antibiotics intended for conditions for which there is high unmet medical need. The FDA’s recent approval of Merck’s Zerbaxa (ceftolozane/tazobactam) and Actavis/AstraZeneca’s Avycaz (ceftazidime/avibactam) and a promising late-stage pipeline (Tetraphase’s IV/oral tetracycline eravacycline, Achaogen’s next-generation aminoglycoside plazomicin, and The Medicines Company’s Carbavance [meropenem/RPX-7009]) will begin to address some of the clinical challenges in this market. Nevertheless, opportunity remains for effective therapies for GNIs due to CROs that can provide meaningful improvements in clinical cure rates and mortality rates without the risk of serious adverse events that characterize many current treatments in this segment of the antibiotics market.