TECH FDA approves new drug for deadly tuberculosis


FDA approves new drug for deadly tuberculosis


07:44, August 15, 2019


Pretomanid, the drug to treat tuberculosis that won FDA approval Wednesday. (Photo: AP)

WASHINGTON, Aug. 14 (Xinhua) -- The US Food and Drug Administration (FDA) approved on Wednesday a new drug for the treatment of a deadly type of treatment-resistant tuberculosis, one of the world's leading infectious causes of death.

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, according to FDA.

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 6 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.

Terms of Service & Privacy Policy

We have updated our privacy policy to comply with the latest laws and regulations. The updated policy explains the mechanism of how we collect and treat your personal data. You can learn more about the rights you have by reading our terms of service. Please read them carefully. By clicking AGREE, you indicate that you have read and agreed to our privacy policies

Agree and continue