After approval of four new ß-lactamase inhibitor (BLI) combinations in the last five years, a new member of the ß-lactam class made it to the finish line. On November 14, 2019 the US Food and Drug Administration (FDA) approved cefiderocol (Fetroja) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative bacteria, in patients with limited or no alternative treatment options. What makes this new antibiotic special? Cefiderocol is the first new cephalosporin since

The traditional model for the development and marketing of new chemical entity (NCE) antibiotics has collapsed. The companies which develop NCEs for resistant bacteria struggle to survive in the market. NCE development costs $200-$500 million per drug for the niche treatment of resistant bacteria, and requires high prices (>$300/day) to recover these development costs. However, these prices force hospitals to further “reserve” new antibiotics until all other options have been exhausted. A challenging market The company Achaogen provides a powerful

Our hospital is a tertiary referral centre in South Africa that manages up to 8000 high-risk deliveries per year of which 45% of newborns are of low birth weight (< 2500 grams). The neonatal unit has > 100 beds available to care for sick newborns (four wards and eight neonatal intensive care beds) and is mostly at full capacity. Prior to December 2018, we had only seen one case of bacteraemia caused by carbapenem-resistant Klebsiella pneumoniae, which belong to

The Global Action Plan on antimicrobial resistance (AMR), endorsed at the World Health Assembly in May 2015, recognised the need for sustainable and increased investment in new medicines, diagnostic tools, vaccines and other interventions. In 2016, the global facing independent review on AMR, led by Lord O’Neill, recommended a global system of market entry rewards. This was also recognised by the G20 leaders’ statement in 2017 which committed to exploring practical market incentive options. Many other governments and international

The antibiotics pipeline is insufficient to address the growing public health threat posed by Gram-negative ESKAPE pathogens—which are among the hardest to treat—and by other antibiotic-resistant bacteria. Of the 42 antibiotics currently in development, only 16 have the potential to target Gram-negative pathogens, and only one of those represents a novel class, according to an analysis by The Pew Charitable Trusts. To stay ahead of resistance, more novel antibiotics targeting Gram-negative bacteria are needed. The brain drain associated with

Despite the many health system challenges faced by resource-poor LMICs, access to new antibiotics used in the treatment of multi-drug resistant (MDR) and extensively-drug resistant (XDR) bacterial infections should be a fundamental right, which must be achieved in order to ensure equity in clinical management of bacterial infection for a global community. Historically this has not been achieved, but rather populations in high income countries have benefitted, first and foremost. This basic right will need to be enabled by

Antimicrobial resistance (AMR) is a massive and growing concern worldwide. What can stop it? It is a complex and far-reaching problem with no easy answers, but we are trying to take important first steps. The REPAIR Impact Fund was launched on the 28th of February 2018. With the first year behind us, I reflect on some surprising lessons learned, thoughts about the future, and finally a more personal perspective. As one of the largest dedicated for-profit life science investors,

The R&D pipeline for new antibacterials to treat increasingly resistant bacterial infections is virtually dry. Very few classes of new antibiotics in particular to treat Gram-negatives have come to the market since the “golden age” of antibiotic discovery. The World Health Organization’s (WHO) global analysis of the clinical pipeline against the priority pathogens in 2017 and 2018 showed that the current pipeline is not very promising to keep up with the evolving resistant bacterial infections with only one of

Great progress on push incentives In the Review on Antimicrobial Resistance (AMR), Lord Jim O’Neill called for a Global AMR Fund with $2 billion over five years. In the past few years, we have seen impressive efforts of new initiatives for research against drug-resistant infections, starting with BARDA, NIAID, Wellcome Trust, JPIAMR, and ND4BB’s ENABLE and TRANSLOCATION projects. In 2016, CARB-X was launched to fund and support innovative early development, GARDP joined the team as a developer, and 2018 saw

A question I’m frequently asked is “with the rise of drug-resistant infections, how does GARDP decide where to focus its efforts”? It’s a reasonable question. And our approach is simple. We consider the priority pathogens identified by World Health Organization (WHO), but also consider the needs and gaps for diseases and key populations when defining which antibiotics to develop. In this way, our efforts focus on global public health priorities and indications less likely to be developed by others.

Six new antibiotics have been approved by the U.S. Food and Drug Administration (FDA) over the last four years. So, at a first glance it seems that there is renewed interest in developing new antibiotics against Gram-negative pathogens. Nevertheless, all six antibiotics – ceftolozane/tazobactam, ceftazidime/avibactam, meropenem/vaborbactam, plazomicin, eravacycline, and omadacycline are improved derivatives of well-known antibiotic classes to address class-specific resistance mechanisms. Five of these antibiotics have been developed against infections mainly caused by Gram-negative pathogens, omadacycline, a tetracyline

When I first started leading the AMR Review in 2014, I soon came to the conclusion that, if the current model wasn’t delivering new antimicrobial drugs, the solution was obvious: launch a new public purpose-focused entity dedicated to developing and producing new antimicrobials. When I shared this hunch with others, I was advised that it couldn’t be done without the major pharmaceutical companies, as they were the only ones with the expertise to produce and distribute drugs. I let this

The views and opinions expressed in this blog are solely those of the original author(s) and do not necessarily represent those of GARDP, their donors and partners, or other collaborators and contributors. GARDP is not responsible for the content of external sites. John H. Rex: Solutions for Antimicrobial Resistance David Shlaes: Antibiotics - The Perfect Storm Longitude Prize - Blog The Center For Disease Dynamics, Economics & Policy (CDDEP)