World Health Organization, Antibacterial pipeline trends and recommendations to enhance research and development: policy brief
This policy brief provides a summary of the trends observed in the antibacterial pipeline and discusses areas that require immediate attention. It calls for policy- makers, funders and global public health organizations to collaboratively recognize, prioritize and act to enable development of novel approaches to curb AMR.
Key points:
• Antimicrobial resistance (AMR) is one of the leading causes of death worldwide and one of the top 10 global health threats identified by the World Health Organization (WHO) (1). Bacterial AMR is estimated to have caused 1.27 million deaths in 2019 and to have been associated with 4.95 million deaths (2).
• The number of antibacterial agents approved and in development is insufficient to tackle the global threat posed by the emergence and spread of drug-resistant infections. Of 128 total clinical programmes in the WHO antibacterial pipeline over the past 6 years, only 16 new antibacterials have received market approval by any stringent regulatory authority or WHOlisted authority.
• The antibacterial pipeline is highly fragile. Ninety-three per cent of developers active in the clinical space are small biotechnology companies, while in the preclinical stage the vast majority (86.7%) of developers are very small, privately funded organizations (11–50 employees) with limited resources.
• There is a continued need for innovative new drugs to combat extensively resistant Gramnegative bacteria, i.e., critical priority pathogens, and the evolving mechanisms of drug resistance. This ongoing need is especially crucial for oral formulations.
• Despite children having the highest AMR disease burden, especially in low- and middle-income countries (LMICs), only six out of 14 late-stage antibiotics in the pipeline have an approved paediatric investigation/study plan (PIP/PSP).
• Over 90% of clinical antibacterial product development takes place in high-income (84%) and upper-middle income (12%) settings, which benefit from more funding opportunities and connections to R&D initiatives in other therapeutic areas.
• More data on the clinical use of newly approved antibacterial agents is urgently needed to understand their effectiveness in different contexts
It then lists 7 challenges, and ends with this conclusion:
Existing antibacterial agents are inadequate against the escalating challenge of drug-resistant infections. Immediate global coordination and cooperation is essential to enhance innovative R&D, improve AMR data collection and sharing, and implement investment strategies that are focused on addressing the needs of vulnerable patients, particularly in LMICs, which lack equitable access to medicines, vaccines and diagnostics despite bearing the greater burden of AMR.
Read the original document at:
https://iris.who.int/bitstream/handle/10665/378316/9789240097735-eng.pdf?sequence=1&isAllowed=y
[Cross-posted with thanks from Public Citizen via the Covid-19-access listserv; WB]