The tablets called Pretomanid is approved in combination with bedaquiline and linezolid for treating a limited and specific population of adult patients with extensively drug-resistant, treatment-intolerant or nonresponsive multidrug-resistant tuberculosis of the lung, FDA said on Wednesday, Xinhua reported.
In 2017, a total of 10 million people fell ill with tuberculosis, and 1.6 million died from the disease, according to the World Health Organization (WHO).
In 2016, there were an estimated 490,000 new cases of multidrug-resistant tuberculosis worldwide, with a smaller portion of cases of highly-lethal extensively drug-resistant tuberculosis, according to WHO.
The new drug's safety and effectiveness, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant pulmonary tuberculosis. Of the 107 patients who were evaluated six months after the end of therapy, 95 (89 percent) were deemed as successes, significantly exceeding the historical success rates for treatment of extensively drug-resistant tuberculosis, according to FDA.
The three-drug regimen with a 6-month treatment also simplifies and shortens the therapy for extensively drug-resistant tuberculosis that previously might take between six and eight drugs for two years or longer.
It is the third FDA-approved anti-tuberculosis drug in more than 40 years.