EMA proposes updating antifungal guidelines to consider latest scientific developments
The European Medicines Agency (EMA) has published a concept paper to update its guidelines on developing antifungal drugs to treat and prevent invasive fungal disease (IFD). The guideline has been updated 17 times since the Committee for Medicinal Products for Human Use (CHMP) first adopted it in 2003, but regulators argue it should be updated again to reflect the latest scientific consensus and regulatory thinking.
EMA highlighted that several new antifungal agents under development show promise for treating rare and emerging pathogens, and some may be effective against pathogens resistant to existing antifungal classes. However, the agency noted that there are many regulatory uncertainties not addressed in the guideline that need to be harmonized with the updated scientific consensus and clarified.
For instance, EMA said that developers of antifungal drugs need more regulatory clarification on minimum data requirements, including primary pharmacology and the translation of pharmacokinetics and pharmacodynamics, and noted that clarity on alternative study designs would be particularly useful. The agency also stated that definitions of IFD and response criteria in clinical studies have been updated by the scientific community and emphasized that the current guidelines should consider updating such information to ensure consistency and applicability across different types of IFD, especially to ensure consistent endpoints and interpretability of clinical trials.
EMA emphasized that the scientific community's definition of a breakthrough infection should be updated in the guideline. The agency said the guideline should be updated to address regulatory requirements for inhaler antifungal drugs under development, especially those that could treat lung fungal diseases.
"Experience has been gained with the assessment of pediatric investigation plans for antifungal agents that may enrich the information presently included in the guidance," said EMA. "Other updates refer to the implementation of principles set up in other relevant guidelines such as the estimands framework (ICH E9(R1)).
"Overall, considering the new developments in the field of IFD there is a need to update the current guideline, especially to reflect the new agents aimed at the treatment of rare and/or emerging pathogens as well as for refractory disease," the agency added.
Stakeholders can comment on the concept paper on EMA's website through 30 September.
