Pretomanid

What is Pretomanid?

The USFDA approved a new drug called Pretomanid. It is only the third new anti-TB drug approved for use by USFDA in over 50 years.It offers hope for the fight against multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) -- the two dreaded forms of TB that defy most drugs.

What are MDR-TB and XDR-TB?

Multi-drug-resistant tuberculosis (MDR-TB) is a form of tuberculosis (TB) infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB medications (drugs), isoniazid and rifampin. Some forms of TB are also resistant to second-linemedications, and are called extensively drug-resistant TB (XDR-TB).

Is it a single drug?

Pretomanid is not a single drug regimen. The drug is used in concert with two other TB medications -- bedaquiline and linezolid over a six-month period.

Who developed Pretomanid?

Pretomanid is developed by a non-profit organisation called the TB Alliance. TB Alliance receives funding from the governments of US, UK, Germany, Australia and the Gates Foundation.

What are the advantages with Pretomanid?

• It is an oral therapy, which means it comes as a pill, making it easier for patients to take the drug
• cut the duration of treatment for drug-resistant TB from 18-24 months to six-nine months. 
•  current cure rates of XDR-TB is 34 percent
• The new regimen also greatly reduces the number of pills required to be taken. A drug resistant TB patient now takes 20 pills a day causing huge side-effects.
• Pretomanid gives a lot of hope to patients, when it comes to access, as it comes from a non-profit organisation heavily funded by tax-payer's money. 

What does it mean for India?

This is an important development for India. It is estimated that 1.47 lakh people in India have MDR-TB, accounting for one-fourth of global burden, as per the Global Tuberculosis Report 2017.Around 6.19 percent of all TB patients in India have MDR-TB. Among MDR-TB patients, the XDR-TB rate was 1.3 percent. Thus, there is a huge unmet need.

Five years ahead of the global target of 2030, India has set an ambitious aim of ending TB by 2025.

What is the voluntary licensing scheme model?

There is the template of Hepatitis-C, where Indian generic companies entered into a voluntary licensing scheme offered by Gilead Sciences on its antiviral drug Sovaldi, to bring the cost of the treatment to hundreds of thousands of patients living in developing and third world countries. This could be a possible direction for Pretomanid to make the drug accessible in countries like India.