News

FDA Approves New Drug for Treatment-Resistant Forms of Tuberculosis

FDA released the following press release on Wednesday, August 14th: 

The U.S. Food and Drug Administration today approved 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, M.D., Ph.D. “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 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. According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.

The safety and effectiveness of Pretomanid, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment intolerant or non-responsive multidrug-resistant pulmonary TB (of the lungs). Of the 107 patients who were evaluated six months after the end of therapy, 95 (89%) were successes, which significantly exceeded the historical success rates for treatment of extensively drug resistant TB.

To read the rest of the FDA's press release please click here

More News
23 Aug 2022
Last week, the PAN-TB collaboration announced initial plans for a Phase 2 clinical trial evaluating two novel drug regimens to treat Tuberculosis. Sponsored by the Bill and Melinda Gates Foundation, the PAN-TB, or “Project to Accelerate New Treatments for Tuberculosis”, collaboration brings...
4 May 2022
Earlier this week, the World Health Organization (WHO) released a rapid communication which detailed the upcoming changes to the treatment guidance for drug-resistant tuberculosis (DR-TB). These guidelines are used to inform national TB programmes globally on how to treat patients with these...
5 Apr 2022
On April 01, 2022, the Stop TB Partnership launched the second online consultation for the new Global Plan to End TB 2023-2030. Over the years, the Global Plans have been important tools for advocacy and resource mobilization, and served as a reference document for donors and stakeholders. In May...