FDA approves new TB drug, first in 40 yrs

The US Food and Drug Administration last week gave its approval to Sirturo, a drug manufactured by Johnson and Johnson which is the first specific anti TB drug in 40 years and has been approved for use in patients of multi-drug resistant TB. The drug, whose chemical name is bedaquiline, is to be used as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis when other alternatives are not available though strict controls have been advocated because of the side-effects that include effects on the heart.

There is a lot of anticipation about the drug in India which is grappling with its massive burden of drug resistant TB. Doctors from Mumbai have already applied for the administration of the drug on compassionate grounds to a patient who has not responded to standard treatment so far. The drug before approval was only available in South Africa on compassionate grounds.

According to WHO figures, India has the largest incidence of drug resistant TB cases, amounting to more than two per cent of fresh cases and about 15 per cent of retreatment cases. In 2010, the total number of cases of drug resistant TB cases in the country was approximately 63,000. According to the Centers for Disease Control and Prevention, nearly nine million people around the world and 10,528 people in the US became sick with TB in 2011.

Multi-drug resistant TB occurs when the TB bacteria Mycobacterium tuberculosis becomes resistant to isonazid and rifampin, two drugs most commonly used to treat TB. Sirturo works by inhibiting an enzyme needed by M tuberculosis to replicate and spread throughout the body.

"This is a new group of drugs targeted specifically against TB, not like quinolones which are basically used because of their wide range of bactericidal activities. We have applied to the company for Sirturo to be applied to one of our patients who we suspect of having totally drug resistant TB on compassionate grounds and we are awaiting the response. But unless we are careful about how often we use the drug not only do we risk the side-effects but it will also go the way of existing TB drugs," Dr Zarir Udwadia, consultant chest physician at Mumbai's Hinduja Hospital said.

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