FDA approve new drug for treatment-resistant TB

pharmafile | August 15, 2019 | News story | Research and Development FDA, TB, US, pharma, pretomanid, tuberculosis 

The US FDA has approved BPaL, the TB Alliance’s treatment for drug-resistant tuberculosis (TB).

The US regulator gave the go-ahead to the TB Allliance’s Pretomanid Tablets as part of a three drug combo, as a treatment for highly treatment-resistant TB of the lungs.

“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner, Dr Amy Abernethy.

“The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”

The TB Alliance, a non-profit organisation based in New York, has granted a licence to Mylan to manufacture and sell the drug.

Speakign to Reuters, a Mylan spokesperson said: “If approved, we expect pretomanid to be available by the end of the year. 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.

Louis Goss

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