New Delhi: A top World Health Organization (WHO) official has flagged concerns over a new tuberculosis drug called delamanid—billed as the potential “wonder drug" solution to multi-drug resistant (MDR) TB—just as India prepares to roll it out as part of its programme to eradicate TB.
“Delamanid failed to show that it adds to efficacy of old WHO MDR TB regimen", WHO’s director of the global tuberculosis programme Mario C. Raviglione tweeted earlier this week.
The tweet followed the release of Phase-III randomized control trial results by Otsuka Pharmaceutical at the 48th Union World Conference on Lung Health in October this year.
Alarmed by the findings, WHO announced preparations for a rapid review of its interim guidance on the use of the drug in the treatment of patients with MDR-TB.
Meanwhile, India is all set to make its first order to procure 400 doses of delamanid this month. India’s is the highest burden of TB in the world. According to Global TB Report 2017 by WHO, an estimated 2.79 million patients were suffering from TB in 2016 and up to 423,000 were estimated to have died from the disease.
In line with WHO requirements, an independent guideline development group is being convened to assess all currently available data on delamanid and to advise WHO on policy implications. The final outcomes of the WHO review of delamanid are expected to become available by early 2018.
The drug billed as “wonder drug" will be limited to those patients who have stopped responding to most of first and second line of treatment. Prior to this, the ministry of health and family welfare had in 2016 rolled out bedaquiline for treating drug resistant TB in 600 patients. It was made available in five cities—Delhi, Chennai, Mumbai, Guwahati and Ahmedabad. “Delamanid will be rolled out in five other cities where MDR TB cases are on the rise," added Kharparde.
Manufactured by Japan’s Otsuka Pharmaceutical Company Limited, delamanid won approval for use in 2014 in Europe, Japan, and South Korea.
The recent trail results have come as a shock for experts. Jennifer J. Furin lecturer on global health and social medicine at the Harvard Medical school in an email response said that, “...In India, there are a significant number of people, including those with resistance to the quinolones and injectables (pre-XDR or XDR) and people who develop side effects to the other drugs (i.e. hearing loss due to injectables). Based on the phase III results, Delamanid should not be added to everyone’s regimen. But Delamanid is a well-tolerated therapeutic option that should be made available to people with resistance or intolerance to other second-line drugs".
Neetu Chandra Sharma contributed to this story.