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FDA Approves New Drug For Hard-to-Treat TB

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The U.S. Food and Drug Administration or FDA has approved a new treatment for highly drug-resistant forms of Tuberculosis that affects the lungs.

Pretomanid in combination with bedaquiline and linezolid has been given the nod to treat a limited and specific adult patients with "extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB."

The three-drug regimen, referred to as the BPaL regimen, was studied in the pivotal Nix-TB trial across three sites in South Africa.

Pretomanid Tablets has been developed by non -profit drug developer The Global Alliance for TB Drug Development or TB Alliance. In April this year, TB Alliance had granted a non-exclusive, worldwide license to healthcare major Mylan to make and sell Pretomanid.

The drug is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. The drug was granted Priority Review, Qualified Infectious Disease Product, and Orphan Drug status. In June of this year, an FDA panel voted 14-4 recommending approval of Pretomanid.

Bedaquiline and Linezolid are approved drugs to treat multidrug-resistant TB.

The FDA called multidrug-resistant TB and extensively drug-resistant TB as public health threats as the bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it.

Pretomanid is the second drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress.

The LPAD pathway is to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.

The first drug approved under the LPAD pathway is Arikayce (amikacin liposome inhalation suspension) to treat lung disease caused by a group of bacteria, Mycobacterium avium complex or MAC.

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