Otsuka had an initial meeting on the matter with the Drug Controller General of India (DCGI) in late 2016, Marc Destito, communications director of Otsuka’s global TB program, told Reuters on Monday. “A follow-up meeting with the DCGI is currently envisioned within the next month to discuss next steps,” Destito said.
There is no clear timeline on when the DCGI will decide on the approval but the submission of the application would start a process that could eventually give thousands of patients with drug-resistant TB in India access to the last-resort drug. Otsuka Pharmaceutical, a subsidiary of Otsuka Holdings, has had a patent on the drug in India for eight years but it has not yet applied for approval to launch it, drawing criticism from international health experts and activists.
Health experts say expanded access to the drug is key for India to achieve its ambitious goal of eliminating TB by 2025. Only a few dozen eligible patients in India have been able to get the drug on request since it was first approved in the European Union in 2014 and thousands more need it.
India’s public health system had about 79,000 drug-resistant TB patients at the end of 2015, according to the World Health Organisation’s (WHO) Global Tuberculosis Report. Actual demand is probably higher, though, as roughly 60 percent of TB patients in India are treated by private clinics.
Destito said Otsuka has held initial talks with the Indian government about making some 400 courses of delamanid available at select treatment centers after approval under a conditional access program. Otsuka is also in talks with the WHO and the Indian Council of Medical Research (ICMR) about making delamanid available to patients in India through a clinical trial later this year.The study would include patients resistant to most standard TB drugs who need delamanid and Johnson & Johnson’s bedaquiline, said ICMR head Soumya Swaminathan, adding that initial talks suggested up to 500 patients could be included.
Delamanid and bedaquiline are the first new TB drugs to be introduced in decades and experts say their rollout has been slow globally to ensure patients do not become resistant.