TB Alliance seeks clinical trial waiver for Pretomanid drug

Hyderabad: TB Alliance, a non profit drug development organisation-is at advanced discussions with India’s drug regulator and has sought clinical trial waiver to launch its newly approved drug-Pretomanid in India, its officials present at the 50th Union World Conference on Lung health at Hyderabad told ET.

Pretomanid, a new oral treatment is a shorter more convenient option for people with extensively drug resistant (XDR) TB.

The dossier for getting approval for the drug has been filed with the drug regulatory authorities. India not only records highest number of TB cases but also bears the maximum burden of XDR TB patients.

“India is the first country where Pretomanid dossier was filed. It happened in July even before FDA approval and clearly it shows the intent of the TB alliance and Mylan to get the drug into India at the highest possibility possible. The discussions with the drug controller have begun, meeting already happened to understand the data. India requires clinical trial to introduce new drugs in the country but there is also a process to waive those clinical trials based on unmet medical need and so given the poor outcomes with XDR patients in India, and the time it will take to generate local data which means you would lose a lot of patients those who could have been saved if one waits for clinical trial…a waiver of clinical trial is being discussed and a meeting did happen,” said Sandeep Juneja, TB Alliance, Senior Vice President – Market Access of the TB Alliance.

Juneja said that TB Alliance is hopeful that the process will go well and quickly and hopefully there will get a waiver to launch the drug in India. “If not one will have to see whatever pathway is suggested by the regulator to bring the drug quickly to India,” he added.

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Pretomanid is the first TB drug to be developed and approved as part of a ready-to-use treatment regimen. It is a cocktail of antibiotic drugs which consists of TB Alliance’s Pretomanid in combination with linezolid and bedaquiline (Bpal) for those TB patients who are non-responsive to other line of treatments.

A newly approved three-drug treatment has been priced at $1,040 for a complete regimen and will be available at $364 per treatment course. It is only the third new medicine approved for drug-resistant tuberculosis in about 40 years, after Johnson and Johnson’s bedaquiline and Mylan and Otsuka Pharmaceutical Co Ltd’s delamanid.

The price of the drug has been criticised by humanitarian organisation MSF (Médecins Sans Frontières) which has demanded that the price of Pretomanid be halved to $500 for a patient. However, drug manufacturing company Mylan which has collaborated to make the experimental drug Pretomanid accessible, said that at this point they are not looking at changes in the pricing of the drug.

“We are really proud of this price and it reflects our current cost of production. At much higher volumes lower cost is possible and we think it’s a good price. We have to agree on specific terms with the government in India there might be variations in price for India but those will be small variations,” said Anil Soni, global head of infectious diseses, Mylan.

Experts say that the accessibility of drug will change the face of TB fight. While the trials of the drug were conducted in parts of Africa, Francesca Conradie, chief investigator in the trial is not doubtful of its efficacy. “There is no reason to suspect that the way it has changed the fight against TB in South Africa it would not be repeated in other countries. The organism is pretty much the same. The first time someone ever got treated with this regimen was 2015 as part of the trial, four years later we have the regime”.

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