EATG » TAG statement on FDA priority review of pretomanid

TAG statement on FDA priority review of pretomanid

Statement from Treatment Action Group on FDA priority peview of TB Alliance’s new anti-TB drug pretomanid.

March 11, 2019 – Treatment Action Group (TAG) welcomes the exciting news of a novel tuberculosis (TB) drug entering priority review by the Food and Drug Administration (FDA). Pretomanid represents only the fourth new TB drug to go through stringent regulatory review in the past half a century, and the first developed by a not-for-profit organization.

Preliminary evidence presented so far from small, uncontrolled studies of a combination of the new drug candidate pretomanid with existing drugs bedaquiline and linezolid indicates that people with especially difficult to treat forms of drug-resistant TB may be able to achieve cure with just six months of treatment. This represents both a reduction in the number of drugs, and the length of treatment, from the current World Health Organization-recommended 18-20 month, four-drug regimens that combine bedaquiline and linezolid with other older and repurposed TB medicines. TAG encourages regulatory stringency with approvals based on large, randomized controlled trials; however, the poor standard of care for extensively drug-resistant TB and poor evidence base for it, and the challenges recruiting people with extensively drug-resistant TB for trials, may justify different research and regulatory approaches in this case.

“People with drug-resistant TB, especially its harder-to-treat forms, urgently need new treatment options, and we welcome the potential for shorter, easier treatment. While we await the FDA’s decision, we urge all countries to follow the latest World Health Organization guidance and move immediately to implement all-oral regimens that are also based on bedaquiline and linezolid,” said Lindsay McKenna, TB project co-director at TAG.

In addition to the submission of this new drug regimen for stringent regulatory review, major developments presented last week at the Conference on Retroviruses and Opportunistic Infections include that TB prevention drug rifapentine is safe to use with HIV drug dolutegravir, and that the two newer drugs bedaquiline and delamanid are safe to use in combination.

“TB research is generating more results than ever. Yet important questions around optimizing treatment for all forms of TB, the need for better diagnostics, the quest for a broadly effective vaccine, and how to best use these critical tools, persist. Continuing this positive momentum requires increased funding for, and meaningful community engagement in, research to ensure that research is rigorous and ethical,” said Mike Frick, TB project co-director at TAG. “If pretomanid is approved, we encourage TB Alliance to commit to reinvesting the earnings from selling the Priority Review Voucher it will receive into innovative mechanisms that support the future of TB research, such as the Life Prize. We encourage donors to continue to fund TB research, and reiterate the call for each country to contribute its fair share to TB research, as committed to at the United Nations High-Level Meeting on TB in September.”

Finally, for pretomanid to make an impact, it must be broadly available, affordable, and accessible to all who need it. This includes setting a flat, low price of USD 1 per day for pretomanid for all countries, in keeping with the Médecins sans Frontières call for a $500 drug-resistant TB regimen and with estimates from University of Liverpool for the price at which pretomanid could be produced and sold at a profit. TAG remains disappointed by the lack of a pre-approval access strategy for pretomanid to date, and the slow pace of development of pretomanid for children, and encourages the TB Alliance, countries, and donors to commit to an equitable development and access strategy for pretomanid and for future treatment options.