FDA approves new drug for deadly tuberculosis
IANS Aug 16, 2019
The US Food and Drug Administration (FDA) approved 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, 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 6 months after the end of therapy, 95 (89 per cent) 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.
Sign-up to continue reading. It is free & takes less than 2 mins
45 lakhs+ doctors trust M3 globally
Free & unlimited access to original articles and quizzes
Secure: we never sell your data
Sign up with M3 India to try daily quizzes and take part in competitionsTry M3 India / Log In
Why join our Market Research Panel?
- 10K+ Doctors participated in 40+ Indian and Global studies in 2018
- Average honorarium per study was Rs. 1,600 and total honoraria as high as Rs. 12,000 was earned by a Doctor