The western media flashed a news report early this month stating that the US FDA  approved a new drug, bedaquiline, for the treatment of multidrug resistant tuberculosis giving hopes to millions of patients suffering from the disease around the world. The FDA approval for a new TB drug, actually a combination of a few drugs, comes after more than 50 years. The drug was discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, and is claimed to be  the first of a new class of drugs that aims to treat the drug-resistant strain of the disease. The FDA. approved bedaquiline under an accelerated programme that allows the agency to conditionally approve drugs that are viewed as filling unmet medical needs with less than the usual evidence that they work. The drug’s approval was based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen, but it did not measure whether in the end patients would actually benefit from bedaquiline. Johnson & Johnson is, therefore, expected to conduct larger clinical trials to investigate whether the drug performs as predicted.

Eradication of tuberculosis continues to be a major health challenge for the authorities of most developing countries in the world today despite regular TB control programmes adopted by governments of these countries for the last several decades. The disease has a serious impact on the economies of these countries as it kills or debilitates people at their very productive age. Twenty two countries, including South Africa bear 80 per cent of the burden of TB worldwide. According to WHO, there are around 9 million new cases of TB detected and close to 2 million people die from the disease each year. In India, TB is rated as a major public health problem and the country accounts for one-fifth of the global TB cases. It is estimated that annually around 3,30,000 Indians die due to TB. And emergence of multidrug-resistant TB in recent years poses a much serious health threat throughout the world. In India, 12 totally drug resistant TB cases were detected at Hinduja Hospital of Mumbai early last year. Detection of these deadly TB cases seems to be rather scary especially when the world is struggling to combat the multi drug resistant TB amongst several lakhs of patients in Asia and Africa. India is the second country to have identified this deadly form of the disease after Iran which had some TDR TB cases four years ago. TDR-TB is caused as a result of the latest mutation of the bacilli bacteria after multi-drug-resistant TB and extremely drug-resistant TB diagnosed earlier. None of the known TB combination drugs work on patients infected by the deadly bacteria. Discovery of  bedaquiline may provide a new hope for patients who are hit by the deadly disease. But as indicated by the US FDA the new drug carries some significant risks as it is still to be tried for its toxicity and effectiveness.