Macleods Gets TB Drug License
In a move that will make treatment of tuberculosis (TB) simpler, accessible, and affordable, global non-profit drug developer TB Alliance has tied up with domestic company Macleods Pharmaceuticals to develop and commercialize its ‘breakthrough’ drug Pretomanid in high-burden countries, including India.
Pretomanid is an essential drug for the treatment of highly drug-resistant TB (DR-TB) if taken along with other TB medicines. It is also the third new anti-TB drug approved by USFDA in over 40 years. Significantly, Macleods has now become the second generic manufacturer for the drug, globally, after the TB Alliance earlier granted rights to US drug maker Mylan in August this year.
Macleods Gets TB Drug License- The Advantage
The license granted to the Mumbai-based company puts to rest doubts about the access and affordability of the new drug, which, when used in combination (with other medications), can cut the duration of the treatment for drug-resistant TB from 18-24 months to six-nine months.
Mel Spigelman, president, and CEO, TB Alliance, said that the licensing agreement with Macleods would allow the company to market Pretomanid as part of the BPaL in approximately 140 countries, which represents the vast majority of the global TB
burden.Macleods Gets TB Drug License- More About TB
Multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB are forms of the disease caused by bacteria that do not respond to first-line anti-TB drugs. Existing treatments, therefore, consist of combinations of many different medications, which are required to be taken for two years (approximately). Patients may take as many as 20 pills a day, resulting in numerous side-effects and a substantial economic burden.
In August, the US Food and Drug Administration (FDA) approved the use of new TB drug Pretomanid as part of a regimen. Besides, Pretonamid, in half a century, only two new drugs have been developed and approved to DR-TB patients: bedaquiline and delamanid.
According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.
Author: Rahul Mishra
