Drugs Controller General of India (DCGI) has approved anti-tuberculosis drug pretomanid for conditional access under the National Tuberculosis Elimination Programme. Pretomanid has been developed by non-profit organisation TB Alliance.
Anti-TB Drug Pretomanid
It is part of a 3-drug, 6-month, all-oral regimen for treatment of pulmonary extensively drug-resistant TB and non-responsive multi drug-resistant TB. Pretomanid is an investigational tuberculosis (TB) drug developed by TB Alliance for use in combination with bedaquiline and linezolid for treating a limited and specific population of adult patients with extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant pulmonary TB.
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Novel compounds are important in pursuing new TB treatments because resistance to drugs and drug classes currently used to treat TB is widespread. It was developed as an oral tablet formulation for the treatment of tuberculosis in combination with other anti-tuberculosis agents. One such combination is BPaL ( bedaquiline + pretomanid + linezolid).
Current therapy for drug-resistant TB often requires people to take drugs for 6 months to 2 years or longer—or risk developing more difficult to treat drug-resistant TB. The WHO reports historical treatment success for XDR-TB at about 34%. BPaL has been tested in drug-resistant TB patients co-infected with HIV, including those receiving antiretrovirals (ARVs).
Pretomanid Tablets are not indicated for patients with:
- Drug-sensitive (DS) tuberculosis
- Latent infection due to Mycobacterium tuberculosis
- Extra-pulmonary infection due to Mycobacterium tuberculosis
- MDR-TB that is not treatment-intolerant or non-responsive to standard therapy
