Mylan gets CDSCO panel nod to manufacture, market Pretomanid for drug resistant TB

“As part of a combination regimen with Bedaquiline and Linezolid, for treatment of multidrug-resistant pulmonary tuberculosis (MDR-TB) or rifampicin-resistance tuberculosis (RR-TB) in patients ≥14 years of age who have no previous exposure (defined as >1 month) to Bedaquiline, Pretomanid, or Linezolid, with Moxifloxacin in the absence of baseline resistance to Fluoroquinolones or without Moxifloxacin if resistance to Fluoroquinolones is present (pre-XDR- TB)”.

Tuberculosis (TB) is an infectious disease usually caused by Mycobacterium tuberculosis (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in which case it is known as latent tuberculosis. Typical symptoms of active TB are chronic cough with blood-containing mucus, fever, night sweats, and weight loss.

Pretomanid is part of a three-drug regimen used for the treatment of extensively drug-resistant and multidrug-resistant pulmonary tuberculosis.

Pretomanid is an antimycobacterial agent that is administered with Bedaquiline and Linezolid to treat resistant forms of pulmonary TB. It was the first TB drug developed by a nonprofit organization, known as TB Alliance, and was granted FDA approval on August 14, 2019.

Pretomanid is indicated, as part of a combination regimen with bedaquiline and linezolid, for the treatment of adults with pulmonary tuberculosis (TB) that is resistant to isoniazid, rifamycins, a fluoroquinolone and a second-line injectable antibacterial drug or adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or non-responsive to standard therapy

Pretomanid exerts aerobic bactericidal effects through its inhibitory actions on bacterial cell wall mycolic acid biosynthesis. This allows for the killing of actively replicating Mycobacterium tuberculosis bacteria, resulting in the treatment of active tuberculosis infection.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the drug Pretomanid Tablets 200mg for the proposed indication with the same condition as the initial approval of the drug.