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Archive - Aug 16, 2019

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FDA Approves New Drug (Pretomanid) for Treatment-Resistant Forms of Tuberculosis That Affects the Lungs; Approval Signals FDA’s Continued Focus on Facilitating Development of New Treatments to Fight Antimicrobial-Resistant Infections

On August 14, 2019, the U.S. Food and Drug Administration announced approval of Pretomanid Tablets, in combination with bedaquiline and linezolid, for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. “The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections. This approval also marks the second time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, a pathway, advanced by Congress, to spur development of drugs targeting infections that lack effective therapies. We hope we continue to see more development of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.” Pretomanid (image shows structure), in combination with bedaquiline and linezolid, is approved for treating a limited and specific population of adult patients with extensively drug-resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB. Multidrug-resistant TB and extensively drug-resistant TB are difficult to treat due to resistance to available therapies.

First-Ever in Vitro Culture Method for Monkey Malaria Parasite Should Allow Rapid, High-Throughput Testing of Possible Drugs for Relapsing Malaria in Humans & Endangered Penguins

A breakthrough in monkey malaria research by two University of Otago (New Zealand) scientists could help scientists diagnose and treat a relapsing form of human malaria. Malaria is a mosquito-borne infectious disease that affects humans and other animals with more than 200 million cases annually, particularly in Asia, the Pacific, and South America. Symptoms include fever, tiredness, vomiting and headaches and, in severe cases, it can cause seizures, coma, or death. Relapsing malaria is caused by the vivax malaria parasite, which is also the most widely distributed and difficult to treat cause of human malaria. Current efforts to develop new drugs and vaccines against vivax have been stymied by lack of a test tube (in vitro) cultured method. However, in a world-first discovery, Dr. Adelina Chua and Jessica Ong have developed an in vitro method for culturing a monkey malaria parasite which is closely related to the relapsing vivax parasite. "We can't culture vivax malaria, but now we can culture its almost identical sister species which gives us an unprecedented opportunity to develop and rapidly test new antimalarials," explained Ms. Ong, a doctoral candidate from the University of Otago Department of Microbiology and Immunology. An interesting spinoff from this research is that the drugs developed against human relapsing malaria also have a good chance of working against bird malaria, which has been killing the endangered yellow-eyed penguin (image) on the New Zealand mainland. "Before our model there was no high throughput model to screen new antimalarials targeting relapsing malaria," Ms. Ong says. "Our model will play a significant part in not only drug development, but also vaccine and diagnostic research."