Pretomanid gained FDA approval for extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary tuberculosis (TB) when used in combination with bedaquiline (Sirturo) and linezolid (Zyvox).
Approval for the oral nitroimidazooxazine antimycobacterial drug, used in an all-oral combination regimen dubbed BPaL or B-L-Pa, was overwhelmingly recommended by an FDA advisory panel in June.
“Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “New treatments are important to meet patient national and global health needs.”
The agency highlighted the approval as only the second in the Limited Population Pathway for Antibacterial and Antifungal Drugs set up by the 21st Century Cures Act in 2016. Under this pathway, labeling must emphasize that safety and efficacy have been shown only for use in a limited population.
An estimated 490,000 new cases of multidrug-resistant TB arose worldwide in 2016, according to the World Health Organization.
Approval hinged on the open-label phase III Nix-TB trial in South Africa. In the 107 patients with extensively drug-resistant, treatment intolerant or non-responsive multidrug-resistant pulmonary TB evaluated 6 months after the end of therapy, 89% were successes, “which significantly exceeded the historical success rates for treatment of extensively drug resistant TB,” the FDA press release noted.
The most common adverse reactions to the combination regimen were peripheral neuropathy, acne, anemia, nausea, vomiting, headache, elevated liver and pancreatic enzymes, dyspepsia, rash, visual impairment, hypoglycemia, and diarrhea.
Pretomanid was developed by the non-profit TB Alliance and will be manufactured and commercialized by Mylan, which is among several companies making linezolid.
Source:: Daily Times