The U.S Food and Drug Administration approved a new drug for the treatment of highly infectious disease i.e Tuberculosis on Wednesday (Aug 14), the drug Pretomanid was approved after determining its ability to treat multidrug-resistant TB (MDR-TB).
Tuberculosis is an infectious disease which kills 1.6 million people each year and it primarily affects the lungs. It can also spread to other parts of the body, like the brain and spine. A type of bacteria called Mycobacterium tuberculosis causes it. Tuberculosis can be fatal if not treated properly and is regarded as the second biggest cause of death globally. Because of inadequate drug treatment, some strains have become drug-resistant. Multidrug-resistant TB (MDR-TB) arises when an antibiotic fails to kill all of the bacteria, with the surviving bacteria developing resistance to that antibiotic and often others at the same time.
MDR-TB is treatable and curable only with the use of very specific anti-TB drugs, which are often limited or not readily available. According to a report in 2012, around 450,000 people developed MDR-TB.
Pretomanid is a part of 3 drug regime against a highly contagious resistant form of TB. The antibiotic was developed and tested by the New York based non-profit organization called TB alliance for better treatment and availability of the drug to poor class society. And the drug is expected to be available in the U.S by the end of this year.
“One definite advantage of a not-for-profit is you don’t have to look at things like returning your profits into shareholders,” Mel Spigelman, president and chief executive of TB alliance tells The Washington Post. TB Alliance has licensed the therapy to Pennsylvania-based pharma company Mylan NV to manufacture and sell pretomanid..”We will focus on the United states and in countries where there is a high burden of extensively drug-resistant TB, the majority of which are low and middle-income markets.” A Mylan spokeswoman tells Reuters.
The pill was approved by the FDA for its use with two other antibiotics i.e bedaquiline and linezolid and in a combination known as BPaL. It is the only 3rd new anti-TB drug approved for use by the FDA in more than the last 40 years.
As per the WHO Global Tuberculosis report 2018, an estimated 4.5 lakh people across the world have MDR-TB and nearly 37500 people have XDR-TB. According to report tuberculosis kills 1.6 million people a year and about 10.4 million falling ill.
With the development of this drug time duration for treating drug-resistant TB found to be shortened from 18-24 months to just 6 months along with the combination of two already approved drug that is bedaquiline and linezolid. According to TB alliance, 95 of the first 107 XDR-TB patients, as well as patients with MDR-TB, were successfully treated with a six-month regime. Along with this the success rate found elevated when the duration time of treatment extended from 6 to 9 months in a few patients. This led to treatment accomplishment of about 91% and potentially decrease the mortality rate as a result of TB.
The FDA has approved the drug based on restricted clinical safety thus the safety and effectiveness of the drug has been studied only when the drug is used in combination with these two antibiotics, bedaquiline and linezolid. Safety of pretomanid has not yet studied to be used with any other anti-TB drug.
All three drugs are to be taken orally. The recommended dosage for pretomanid is 200mg drug once every day for 26 weeks, while 1200mg of linezolid once daily for upto 26 weeks. In the case of bedaquiline, the dosage and its frequency changes mid-course.