Mylan gets DCGI approval to market anti-TB drug Delamanid
New Delhi: Indian unit of US drug maker Mylan Inc. has received approval from the country’s drug regulator DCGI to market Delamanid, a new class of anti Tuberculosis (TB) medicine discovered to specifically treat Multi Drug Resistant TB (MDR) in India.
Like Bedaquiline, which was the first TB drug launched in 40 years in 2016, Delamanid’s treatment will be “limited” to those patients who have stopped responding to most of first and second line of treatment. The drug billed as “wonder drug” will be rolled out in government-run-TB programme. Prior to this, the ministry of health and family welfare had in 2016 launched Bedaquiline drug for treatment of drug resistant TB for 600 patients across India. It was made available in five cities-Delhi, Chennai, Mumbai, Guwahati and Ahmedabad.
With cases of multi drug resistant (MDR) and extensively drug resistant (XDR) TB rising in India, the new drug-Delamanid 50mg could benefit large number of people suffering from the infectious disease.
“With the risk of bacterial resistance to this new class of drug, the government is cautious against rolling it out for every TB patient. Delamanid is indicated for treatment of pulmonary TB due to multi-drug resistant Mycobacterium TB for which presently there are not many effective therapies available in India,” said Saumya Swaminathan, director general (DG) of Indian Council of Medical Research (ICMR) and clinical scientist known for her work in Tuberculosis. According to Swaminathan improved access to Delamanid in the country is critical to control the global spread of drug-resistant strains of the disease.
Manufactured by Japan’s Otsuka Pharmaceutical Co. Ltd, Delamanid got approval for medical use in 2014 in Europe, Japan, and South Korea. In India, DCGI recently recommended “waiver of local clinical trials at this stage” and approved the drug with a restriction that it “shall be approved for use under government run Revised National TB Control Programme (RNTCP)” and for conditional access for treatment of MDR-TB patients only. An email seeking comments sent to Mylan’s public relations team remained unanswered till press time.
The approval to the drug in India has come as a respite where TB kills two Indian every three minutes and drug resistance is growing at an alarming pace. India accounted for 2.8 million new TB cases in 2015, an increase from 2.2 million in 2014. According to the government data, every year over 99,000 new drug resistant patients are diagnosed with TB. According to the WHO drug resistant cases are escalating demanding long treatment duration which also result in higher chances of drop outs.
“In parallel we are discussing with the company to conduct clinical trials combining both Bedaquiline and Delamanid. The trial protocol has been approved by the DCGI. Our aim is to reduce the duration of the treatment from currently 30 months to 6-9 months,” added Swaminathan.
“We are unable to provide any details at this point,” a Mylan spokesperson said, responding to an email.