FDA approves new drug for resistant TB
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
The US Food and Drug Administration (FDA) approved pretomanid as part of a three-drug, six-month oral regimen to treat patients with extensively drug-resistant (XDR) tuberculosis who do not respond to most other known anti-TB drugs.

US drug regulators on Wednesday approved a new compound for use with two other drugs to treat the deadliest form of tuberculosis, with health activists saying it should be made affordable to patients in developing countries.

The FDA decision follows a clinical trial at three sites in South Africa that recorded successful outcomes in 95 of 107 patients with XDR-TB or with treatment-intolerant or unresponsive multi-drug resistant (MDR)-TB.

In the trial called Nix-TB, patients received pretomanid in combination with bedaquiline and linezolid, and were followed up for six months after therapy.

This regimen “will hopefully provide a shorter… and highly efficacious treatment” for people suffering from highly drug-resistant forms of TB”, said Mel Spigelmman, president and chief executive officer of TB Alliance, a not-for-profit organisation that acquired developmental rights for the drug in 2002.

Current therapy for XDR-TB involves combinations of up to eight antibiotics, some of them daily injections, taken for 18 months or longer.

Although XDR-TB is rare — the World Health Organisation estimated that 6 per cent of MDR-TB patients in 2016 had XDR-TB — the current treatment success rates are about 34 per cent, described by doctors as “abysmally low”.

“People infected with highly drug-resistant TB had poor treatment options and poor prognosis,” said Francesca Conradie, the principal investigator of the Nix-TB trial.

“This new regimen provides hope with nine out of 10 patients achieving culture-negative (tubercular bacilli undetectable) at six months after treatment.”

Pretomanid, based on a compound called PA-824, which was discovered by US researcher Ken Stover and his colleagues about two decades ago, is only the third new anti-TB drug approved by regulators in over 40 years.

The international humanitarian agency Medecins Sans Frontieres on Thursday hailed the regulatory approval to pretomanid but said “the drug must be made affordable to everyone who needs it”.

The first nationwide survey for drug-resistant TB by the Indian health ministry had two years ago estimated that India had about 147,000 MDR-TB patients, a fourth of the global burden. Among these MDR-TB patients, 1.3 per cent had XDR-TB.

Source: https://www.telegraphindia.com/health/nod-to-drug-to-treat-deadliest-tuberculosis/cid/1698108
Dr. S●●●●●●e C●●●●●●●y and 55 others like this49 shares
Dr. P●●●●●l
Dr. P●●●●●l General Medicine
Ken Stover and his colleagues respect?
Aug 17, 2019Like1
A●●●●●a M●●●●●●d
A●●●●●a M●●●●●●d General Medicine
A milestone in TB treatment!
Aug 17, 2019Like
Dr. V●●●●a  R●●●n
Dr. V●●●●a R●●●n Ophthalmology
Wish such Discovery had occurred earlier, it could have saved million of lives.
Aug 17, 2019Like1