FDA approves new drug for deadly tuberculosis
The tabletscalled Pretomanid is approved in combination with bedaquiline and linezolid fortreating a limited and specific population of adult patients with extensivelydrug resistant, treatment-intolerant or nonresponsive multidrug resistanttuberculosis of the lung, according to FDA, Xinhua reports.
In 2017, atotal of 10 million people fell ill with tuberculosis, and 1.6 million diedfrom the disease, according to the World Health Organization (WHO).
In 2016,there were an estimated 490,000 new cases of multidrug-resistant tuberculosisworldwide, with a smaller portion of cases of highly-lethal extensivelydrug-resistant tuberculosis, according to WHO.
The newdrug's safety and effectiveness, taken orally in combination with bedaquilineand linezolid, was primarily demonstrated in a study of 109 patients withextensively drug-resistant pulmonary tuberculosis. Of the 107 patients who wereevaluated 6 months after the end of therapy, 95 (89 percent) were deemed assuccesses, significantly exceeding the historical success rates for treatmentof extensively drug resistant tuberculosis, according to FDA.
Thethree-drug regimen with a 6-month treatment also simplifies and shortens thetherapy for extensively drug resistant tuberculosis that previously might takebetween six and eight drugs for two years or longer.
It is thethird FDA-approved anti-tuberculosis drug in more than 40 years.