“The treatment of XDR-TB has been dire ever since this form of the disease was discovered,” said Jay Achar, infectious disease specialist and TB medical advisor at MSF. “Having access to effective treatment regimens will give people hope of a cure, and help programmes limit transmission of this deadly bacteria. While safer, simpler regimens are still needed, the shorter treatment duration of this novel regimen is an important step in the right direction.”
Pretomanid was developed by TB Alliance, a not-for-profit organisation, funded by governments (e.g. Australia, Germany, the UK and the US) and philanthropic sources, with the expectation that the organisation would hold true to its stated mission, that they are “dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those who need them.”
In addition, TB Alliance stands to be granted a tropical disease priority review voucher (PRV)*, which it can sell for a substantial amount: PRVs have previously been sold for US$67-350 million.
MSF calls for TB Alliance to use this financial reward to ensure that the drug gets registered and made available at an affordable price, fast.
“This newly approved regimen containing pretomanid could be a lifesaver for people with XDR-TB, but it’s not time to celebrate yet,” said Sharonann Lynch, HIV & TB policy advisor for MSF’s Access Campaign. “The approval of this new regimen by the US FDA is just the first step. We now need pretomanid to be registered and available at an affordable price in all countries, prioritising those with the highest TB burden.”
In April this year, TB Alliance granted the first license to the US pharmaceutical corporation Mylan to manufacture, register and supply pretomanid.
To date, TB Alliance and Mylan have not made the price of pretomanid public. It has been estimated that generic versions of pretomanid could be produced and sold at a profit for between US$0.36 and US$1.14 per day.
The lowest global prices for the other two drugs in the regimen, bedaquiline and linezolid, already run at around US$3 per day; people needing this treatment regimen would have to take it for six months, amounting to a total price of US$548, before considering the additional price of pretomanid.