News

Monday, March 21, 2016

Government to launch Bedaquiline, first TB drug approved by FDA in 40 years

Bedaquiline was described for the first time in 2004 at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, after the drug had been in development for over seven years.
One of the first published trials of Bedaquiline was a Phase II trial of 47 patients, which showed that the drug was effective in reducing the time to TB-free sputum cultures. A subsequent phase II efficacy trial was published in 2010 and sponsored by Tibotecand the TB Alliance.
It is manufactured by Johnson & Johnson (J&J), who sought accelerated approval of the drug, a type of temporary approval for diseases lacking other viable treatment options.[11] By gaining approval for a drug that treats a neglected disease, J&J is now able to request expedited FDA review of a future drug.
According to a leading daily, the treatment has been rolled out under the Revised National Tuberculosis Control Programme and is part of co-ordinated programme between the government and Johnson & Johnson.
The drug will be made available in six public hospitals in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad.
Named 'Bedaquiline' (trade name Sirturo), the drug is perhaps the first in decades to have a potential to dramatically improve multi-drug resistant tuberculosis (MDR-TB) treatment outcomes, and reduce the number of people who die from the disease.
India has the highest burden of tuberculosis in the world with over 2.5 million people living with TB every year. As per World Health Organisation (WHO) Global Tuberculosis Report 2015, for the year 2014, deaths due to TB were estimated in India to be 2,20,000 which is higher than any other country.

No comments :

Post a Comment