LINDAU, GERMANY: A newly launched tuberculosis drug for the treatment of multi drug resistant TB (MDRTB) might not be without side effects and governments should be cautious while administering the drug, Nobel Laureate Sir John Walker told ETin an interview.
The 1997 Nobel winner in chemistry, who was one of the speakers at the Lindau Nobel Laureates meeting, said clinical data showed that the drug has side effects such as raising cardiovascular risks and, in some cases, causing unexplained deaths.
"One should always be cautious when it comes to using new agents like these. There might be unforeseen circumstances that may arrive yet because clinical trials (that) have been conducted have been quite limited, with only phase 2 clinical trial with 440 people. So, it would be unwise to use in large populations," Walker explained. Bedaquiline sold under the brand name Serturo is the first antibiotic drug to come into the market in 40 years. India is one of the few countries where US drug maker Jansen (a part of Johnson and Johnson) has offered the drug free of cost under a conditional access program.
India has a third of the world's MDR TB populations as the current drugs used to treat the disease have become resistant for several patients. Bedaquiline was approved by the USFDA in 2012 on the basis of the company's phase 2 data and approved for use in 53 countries. In India the drug was approved in 2015 by the drug controller, and there were five patients who were part of the worldwide trial, on the basis of which Jansen got a phase three waiver.
This is what has alarmed scientists like Walker. "We should wait for more data to emerge. You have to approach in a step-wise manner and expand gradually once it becomes clear if there are not any contraindications," he said.
In an email response to ET’s questions, J&J said it has communicated the safety aspects of bedaquiline to the Indian government, and trained more than 12,000 physicians on the clinical management of the drug. The patient information booklet also covers drug safety information.
"As the first new TB drug to be made available in the last 50 years, Janssen is working diligently with health authorities and medical experts around the world to introduce it in a way that ensures optimal treatment outcomes for patients and reduces the likelihood of rapid resistant forms of TB bacteria emerging," a J&J spokesperson told ET.