ET Bureau Aug 16, 2019, 11.14 AM IST
MUMBAI: The USFDA has approved a new tuberculosis drug to treat extreme drug-resistant TB (XDR-TB), the first developed by a not-for-profit organisation, and the therapy could help patients in countries such as India where the impact of the infectious disease is evident.
Pretomanid, a new chemical entity, was under development since 2002 by the TB Alliance. Patrons of this organisation developing the drug include the Bill and Melinda Gates Foundation, the foreign ministries of Australia, Netherlands, and the UK, and Indonesia’s Health Fund. This is only the third drug for TB to have been approved by the USFDA in the past 40 years. The other two are Bedaquiline, developed by Johnson and Johnson, and Delamanid by Japanese drug maker Otsuka Pharma.
XDR-TB is a condition in which a patient remains unresponsive to all the available antibiotics for treating the TB bacteria. Currently, patients suffering from XDR TB must take a combination of eight forms of antibiotics, including daily injections, for 18 months. Pretomanid is an oral dose form and is a sixmonth regimen. The drug is to be taken with Bedaquiline and Linezolid, another antibiotic.TB Alliance has given manufacturing rights of the drug to US drug maker Mylan, and it is expected to be launched in the US by the end of this year.
However, there are concerns over the pricing of Pretomanid. TB Alliance has not disclosed yet at what cost will it be offering the drug to patients. Doctors Without Border, a humanitarian organisation, has sought pricing below $500 per person for a complete course. As per World Health Organization, by the end of 2016, XDR-TB has been reported by 123 WHO member-states. The WHO says that information from countries with reliable data suggests that about 6.2% of MDR-TB cases worldwide have XDR-TB.