Pretomanid is only the third new anti-TB drug to be approved for use by USFDA in over 40 years
There was finally some good news in 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.
The USFDA on August 14 approved a new drug called Pretomanid. It is only the third new anti-TB drug approved for use by USFDA in over 40 years.
Pretomanid is part of the same class of drugs (nitroimidazoles) as delamanid -- one of the other two TB drugs approved in the last half century, developed by pharmaceutical corporation Otsuka.
Interestingly, the new TB drug 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. The organisation has granted the first manufacturing license of Pretomanid to US drug maker Mylan.
Pretomanid is not a single drug regimen. The drug is used over a six-month period in concert with two other TB mediciations -- bedaquiline, a drug manufactured by Janssen Pharmaceuticals, owned by Johnson & Johnson and linezolid, which is a generic.
There are several advantages of Pretomanid. It is an oral therapy, which means it comes as a pill, making it easier for patients to take the drug and for companies to manufacture.
The new drug, when used in combination, had cut the duration of treatment for drug-resistant TB from 18-24 months to six-nine months. In one trial in South Africa, out of the 107 patients with extensively drug-resistant TB given this oral regimen, 89 percent were treated successfully. The 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 pop-up 20 pills a day causing huge side-effects.
Given the importance of the drug in treating MDR-TB, Pretomanid was given a priority review status, where USFDA fast tracks approval process, giving certain relaxations like abridged clinical trials.
Pretomanid is also eligible for priority review voucher (PRV). US government grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment.
The voucher is transferable and can be sold, also entitles the bearer to a priority review for another product. PRVs have previously been sold for $67-350 million.
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 and a priority review status by USFDA saving lot of time and expenditure.
Everything about Pretomanid seems to be good. But, concerns still remain about pricing. So far, neither the commercial partner Mylan nor TB Alliance has made the licensing agreement public. The pricing of the drug remains a mystery.
Mylan is expected to bring Pretomanid to market by January 2020. However, this is dependent on World Health Organization (WHO) guidance on using the drug, and on Mylan filing for registration in countries with the highest DR-TB burden.
Doctors Without Borders/Médecins Sans Frontières (MSF) - MSF has called for treatment of drug-resistant TB to be no higher than $500 per person for a complete treatment course.
MSF estimates that generic versions of Pretomanid could be produced and sold at a profit for between $0.36 and $1.14 per day. The current cost of six month treatment with bedaquiline and linezolid is $548, according to the Paris based non-governmental organisation.
Pretomanid is an alternative to Delamanid, a patented product which is not accessible to most patients given its cost. The lowest price of a six-month treatment course remains $1,700. People need the drug to taken for up to 20 months.Janssen also follows tier-pricing for bedaquiline. The company offers bedaquiline at a not-for-profit price of $400 per treatment course in more than 130 countries, including India, via the Stop TB Partnership’s Global Drug Facility (GDF).
Implications in 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. There is clearly an unmet need.
Currently, India gets around 10,000 courses of bedaquiline from J&J free of cost under a conditional access programme.
India administers the drug through a highly controlled, government monitored programme. But, J&J’s drug donation is not sufficient to treat all Indian patients. Moreover, when J&J decides to end its conditional access programme as it did in many countries, India may be left in quandary.
There is the template of Hepatitis-C, where Indian generic companies took advantage of licensing scheme offered by Gilead Sciences on its antiviral drugs 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.(The story was updated on August 20, with Janssen's bedaquiline pricing information)The Great Diwali Discount!
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