Saturday 14 January 2023

New guidance on developing tuberculosis drugs


Image: CDC/Dr. George Kubica - This media comes from the Centers for Disease Control and Prevention's Public Health Image Library (PHIL), with identification number #4428

Infections caused by Mycobacterium tuberculosis (M. tuberculosis) are endemic in many parts of the world. Resistance to multiple drugs and coinfection with human immunodeficiency virus (HIV) pose challenges in the management of tuberculosis (TB). Drugs with new mechanisms of action, improved safety profiles, fewer drug-drug interactions, and treatment-shortening combination regimens are needed to manage TB. 

By Tim Sandle.

Activity of antimycobacterial drugs can be evaluated in trials of early bactericidal activity (EBA) and/or in phase 2 trials that evaluate microbiological outcomes at early time points. For a combination regimen, the sponsor should evaluate the contribution of each drug to the treatment effect.

TB is a bacterial infection spread through inhaling tiny droplets from the coughs or sneezes of an infected person. Here, TB is spread from person to person through the air. When people with lung TB cough, sneeze or spit, they propel the TB germs into the air. A person needs to inhale only a few of these germs to become infected. 

TB is a serious condition, but can be cured with proper treatment. TB mainly affects the lungs. However, it can affect any part of the body, including the glands, bones and nervous system. Common symptoms of active lung TB are cough with sputum and blood at times, chest pains, weakness, weight loss, fever and night sweats.

According to the World Health Organisation, a total of 1.6 million people died from TB in 2021.

The Food and Drug Administration has issued a draft guidance for industry entitled “Pulmonary Tuberculosis: Developing Drugs for Treatment.”

The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). New drugs are needed due to the rise of antimicrobial resistant strains. Multidrug-resistant tuberculosis (MDR-TB) is a form of TB caused by bacteria that do not respond to isoniazid and rifampicin, the 2 most effective first-line TB drugs.  TB caused by bacteria that do not respond to the most effective second-line TB drugs can leave patients with limited treatment options.

This draft guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB. 


The guidance can be accessed here.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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