Concerned over the rise of infectious diseases which cover the coronavirus disease and tuberculosis among others, the USFDA has issued draft norms on antibacterial therapies to put in place a system of treatment.
The regulator awaits its comments and suggestions by July end, 2022.
The guidance is intended to assist sponsors in the clinical development of new antibacterial drugs.
Indian medical experts view it as an important development as there are several patients suffering and succumbing to drug resistance antibacterial therapies.
It is specifically related to the clinical trial designs for antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients for which effective antibacterial drugs are limited or lacking.
Bacteria that has developed resistance to antibiotics included MRSA (methicillin-resistant Staphylococcus aureus), Clostridium difficile and multi-drug-resistant tuberculosis.
Antibacterial drugs that are active against only a single species or few species within a genus of bacteria can be developed for the treatment of serious bacterial diseases.
The regulatory authority said that there are significant changes in this draft guidance from the 2017 version include the possibility to conduct non-inferiority trials that include subjects with infections caused by certain drug-resistant pathogens since effective active controls are now available.
Since antibacterial drug resistance continues to be a public health concern, it has led to an increasing number of patients with serious bacterial diseases, such as hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections, who may not respond to currently available antibacterial drugs.
Conducting clinical trials to evaluate antibacterial drugs for the treatment of subjects with a serious bacterial disease can be challenging for a number of reasons, including the need to promptly initiate empiric antibacterial therapy to reduce the risk of morbidity and mortality.
The severity of the acute illness in subjects like delirium in the setting of acute infection may make obtaining informed consent and performing other trial enrollment procedures difficult.
There is also diagnostic uncertainty with respect to the etiology of the subjects’ underlying disease, said the regulator.
The draft indicates that the candidates for a flexible development programme are intended to treat serious bacterial infections in patients who have few or no available treatments.
Such drugs are likely to have a new mechanism of action that preserves antibacterial activity against bacteria that have mechanisms of resistance to other available antibacterial drugs.
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