The World Health Organisation (WHO) has published its first-ever report addressing the critical lack of medicines and diagnostic tools for invasive fungal diseases, showing the urgent need for innovative research and development (R&D) to close these gaps.
The report highlights that, in the past decade, only four new antifungal drugs have been approved by regulatory authorities in the United States, the European Union or China, yet fungal diseases are an increasing public health concern, with common infections like candida – causing oral and vaginal thrush – growing increasingly resistant to treatment.
These infections disproportionately affect severely ill patients and those with weakened immune systems, including people undergoing cancer chemotherapy, who have HIV, and who have had organ transplants.
“Invasive fungal infections threaten the lives of the most vulnerable but countries lack the treatments needed to save lives,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Antimicrobial Resistance ad interim.
“Not only is the pipeline of new antifungal drugs and diagnostics insufficient, there is a void in fungal testing in low- and middle-income countries, even in district hospitals. This diagnostic gap means the cause of people’s suffering remains unknown, making it difficult to get them the right treatments.”
The fungi in the top “critical priority” category of the WHO’s fungal priority pathogens list (FPPL) are deadly, with mortality rates reaching as high as 88%.
Advancements in treatments mean that people are likely to have immunocompromised conditions, which also could mean increases in cases of invasive fungal diseases. This is a complex challenge to manage due to inaccessibility of diagnostic tools, limited availability of antifungal medicines, and a slow and complex R&D process for new treatments.
Currently, nine antifungal medicines are in clinical development to use against the most health-threatening fungi, as detailed in the FPPL.
However, only three candidates are in phase 3, the final stage of clinical development, meaning few approvals are expected within the next decade.
Twenty-two drugs are in preclinical development, an insufficient number to feed a clinical pipeline considering the dropout rates, risks and challenges associated with earlier development stages.
Issues with current antifungal treatments include serious side effects, frequent drug-drug interactions, limited dosage forms and the need for prolonged hospital stays. The report highlights the urgent need for safer antifungal medicines, possibly reducing requirements for continuous drug monitoring.
Antifungal medicines that work against a wide range of severe infections caused by fungal priority pathogens are also needed.
WHO recommends investing in global surveillance, expanding financial incentives for drug discovery and development, funding basic research to help identify new and unexploited targets on fungi for medicines, and investigating treatments that work by enhancing patients’ immune responses.
Landscape report of diagnostics for fungal priority pathogens
The report shows that while commercially available tests exist for fungal priority pathogens, these rely on well-equipped laboratories and trained staff, meaning most people in in low- and middle-income countries (LMICs) do not benefit from them.
All countries, but particularly LMICs, need faster, more accurate, cheaper and easier testing for a broad range of fungal priority pathogens, including diagnostic tools that can be used at or near point-of-care.
The WHO, which calls for strengthening the global response against invasive fungal diseases and antifungal resistance, is also developing an implementation blueprint for the FPPL.
WHO fungal list
WHO article – WHO issues its first-ever reports on tests and treatments for fungal infections (Open access)
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