The August 14 approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs.
The US Food and Drug Administration (FDA) approved a new medication for treatment-resistant forms of tuberculosis (TB) that affects the lungs, making it the second ever drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs.
The FDA announced on Aug. 14 the approval of Pretomanid Tablets in combination with bedaquiline and linezolid to treat the specific form of TB of the lungs.
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement. “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.”
The FDA approved the drug to treat a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.
According to the World Health Organization (WHO), there were an estimated 490,000 new cases of multidrug-resistant TB worldwide in 2016, with a smaller portion of cases of extensively drug-resistant TB.
Investigators recently conducted a 109-patient clinical trial to prove the safety and effectiveness of Pretomanid, taken orally in combination with bedaquiline and linezolid.
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.
Some of the common adverse reactions found include damage to the nerves, acne, anemia, nausea, vomiting, headache, increased liver enzymes, indigestion, rashes, increased pancreatic enzymes, visual impairment, low blood sugar, and diarrhea.
Abernethy said the new treatment are part of an initiative approved by Congress focusing on the development of drugs targeting infections that lack effective therapies.
“New treatments are important to meet patient national and global health needs,” she said. “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.”
Pretomanid also received the FDA’s Qualified Infectious Disease Product (QIDP) designation given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.