FDA approves pretomanid to treat extensively drug-resistant TB

August 16, 2019 0 By FM

The US Food and Drug Administration has approved pretomanid for the treatment of extensively drug-resistant tuberculosis (TB) to be used in combination with bedaquiline and linezolid.

The drug combination is approved for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or non-responsive multidrug resistant pulmonary TB.

Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options.

According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.

The safety and effectiveness of pretomanid, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment intolerant or non-responsive multidrug-resistant pulmonary TB.

Of the 107 patients who were evaluated six months after the end of therapy, 95 (89%) were successes, which significantly exceeded the historical success rates for treatment of extensively drug resistant TB, reports FDA.

The FDA granted the approval of pretomanid tablets to The Global Alliance for TB Drug Development (TB Alliance).

“Until now, the best option cured about two-thirds of patients, took 18 to 30 months and required up to eight kinds of shots and pills. Many patients die or don’t finish treatment”, according to Mel Spigelman,CEO, TB Alliance.

The new combo could help over 75,000 patients per year, mostly in India, China, Indonesia, South Africa and Nigeria, he said.

The FDA’s action should bring quick approval in countries where it’s endemic. The alliance will work with the WHO to speed adoption of the treatment in those countries. The alliance is contracting with multiple generic manufacturers to make pretomanid and keep it affordable.