FDA News

FDA accepts NDA for pretomanid in combination TB regimen

TB Alliance announced that the FDA has accepted a new drug application for its novel tuberculosis drug candidate, pretomanid, as part of a drug regimen used to treat extensively drug-resistant TB; treatment-intolerant, multidrug-resistant TB; and treatment-nonresponsive, multidrug-resistant TB.

Pretomanid, a member of a class of compounds known as nitroimidozooxazines, would be used in combination with bedaquiline and linezolid. It has been studied in 20 clinical trials alone and in combination with other anti-TB drugs and has been administered in a clinical trial setting to more than 1,200 people in 14 countries, according to TB Alliance.

The regimen of bedaquiline, pretomanid and linezolid (BPaL) was first studied clinically in the phase 3 Nix-TB trial in South Africa. Researchers enrolled patients aged 14 years and older (mean age, 35.2 years) with extensively drug-resistant TB and treatment-intolerant or nonresponsive multidrug-resistant TB. Patients were treated with BPaL for 6 months, which was extendable to 9 months, with intent to cure.

According to a modified intent-to-treat analysis of interim results of the first 75 patients, 89% of study participants had a favorable outcome, with their clinical infection resolved and sputum cultures negative for TB after 6 months of treatment and 6 months of post-treatment follow-up.

The FDA granted priority review of the NDA, with a Prescription Drug User Fee Act action date expected in the third quarter of 2019, according to TB Alliance.

References:

Conradie F, et al. Abstract OA03-213-25. Presented at: The Union World Conference on Lung Health; October 24-27, 2018; The Hague, the Netherlands.

Conradie F, et al. Abstract 80LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.

TB Alliance announced that the FDA has accepted a new drug application for its novel tuberculosis drug candidate, pretomanid, as part of a drug regimen used to treat extensively drug-resistant TB; treatment-intolerant, multidrug-resistant TB; and treatment-nonresponsive, multidrug-resistant TB.

Pretomanid, a member of a class of compounds known as nitroimidozooxazines, would be used in combination with bedaquiline and linezolid. It has been studied in 20 clinical trials alone and in combination with other anti-TB drugs and has been administered in a clinical trial setting to more than 1,200 people in 14 countries, according to TB Alliance.

The regimen of bedaquiline, pretomanid and linezolid (BPaL) was first studied clinically in the phase 3 Nix-TB trial in South Africa. Researchers enrolled patients aged 14 years and older (mean age, 35.2 years) with extensively drug-resistant TB and treatment-intolerant or nonresponsive multidrug-resistant TB. Patients were treated with BPaL for 6 months, which was extendable to 9 months, with intent to cure.

According to a modified intent-to-treat analysis of interim results of the first 75 patients, 89% of study participants had a favorable outcome, with their clinical infection resolved and sputum cultures negative for TB after 6 months of treatment and 6 months of post-treatment follow-up.

The FDA granted priority review of the NDA, with a Prescription Drug User Fee Act action date expected in the third quarter of 2019, according to TB Alliance.

References:

Conradie F, et al. Abstract OA03-213-25. Presented at: The Union World Conference on Lung Health; October 24-27, 2018; The Hague, the Netherlands.

Conradie F, et al. Abstract 80LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.