Bedaquiline: New drug J & J TB not without side effects: Sir John Walker

LINDAU, GERMANY: A new anti-tuberculosis drug for the treatment of multidrug-resistant tuberculosis (MDRTB) may not be without side effects and governments should be cautious when administering the drug, said Sir John Walker, Nobel laureate.

The 1997 Nobel Laureate in Chemistry, who was one of the speakers at the Lindau Nobel Laureate Meeting, said the drug had side effects such as the increase in cardiovascular risks and, in some cases, unexplained deaths.

"One should always be careful when it comes to using new agents like these. There may be unforeseen circumstances that may happen again because clinical trials have been quite limited, with only a phase 2 clinical trial with 440 so it would be unwise to use in large populations, "explained Walker. Bedaquiline sold under the Serturo brand is the first antibiotic to enter the market for 40 years. India is one of the few countries where American drug maker Jansen (part of Johnson and Johnson) offered the drug free of charge as part of a conditional access program.

India accounts for one-third of the world's multidrug-resistant TB populations because the drugs currently used to treat the disease have become resistant to many patients. Bedaquiline was approved by the USFDA in 2012 based on Phase 2 data from the company and approved for use in 53 countries. In India, the drug was approved in 2015 by the drug controller, and five patients participated in the global trial, on the basis of which Jansen obtained a third-stage waiver.

This is what alarmed scientists like Walker. "We should wait for other data to appear, we have to approach in stages and gradually expand once it becomes clear that there is no countermeasures. -indications, "he said.

In an e-mail response to ET questions, J & J said it had communicated the safety aspects of bedaquiline to the Indian government and trained more than 12,000 physicians in the clinical management of the drug. The patient information booklet also covers information on the safety of medications.

"As the first new antituberculosis drug to be available in the last 50 years, Janssen is working diligently with health authorities and medical experts around the world to introduce it to ensure treatment outcomes. optimal for patients and reduce it, "said a spokeswoman for J & J at ET.

(This correspondent received a scholarship to attend the 68th Lindau Nobel Prize Meeting in Lindau, Germany.)