US FDA Approves New TB Drug in Treatment to Cure Practically Incurable XDR-TB

Statement from Jamie Bay Nishi, Director, Global Health Technologies Coalition, on the US Food and Drug Administration’s approval of pretomanid, a new drug developed by the nonprofit TB Alliance

WASHINGTON, DC—The ticking time bomb of extensively drug-resistant tuberculosis (XDR-TB), an infection that is easy to transmit and almost impossible to cure, has been defused. Today, a new drug, pretomanid, has been approved by the US Food and Drug Administration (FDA) for use in a treatment for XDR-TB. Amazingly, it’s the first time that a treatment for XDR-TB infections has been recognized for actually working—no other treatment has demonstrated any consistent effectiveness.

Up until now, people with XDR-TB had to suffer through up to two years or more of toxic treatment that worked only one third of the time. Today’s news means that treatment time is drastically reduced—to six months—while the effectiveness of treatment is significantly improved.

We welcome this approval as it shows the real-world impact of US government investment in finding new cures and vaccines for the world’s deadliest diseases. The developer of pretomanid, the nonprofit organization TB Alliance, could not have succeeded in advancing this breakthrough without support from the American people, through the US Agency for International Development (USAID) and National Institutes of Health (NIH).

As federal spending for the coming fiscal year continues to be debated in Congress, we hope that this breakthrough bolsters our commitment to fighting global diseases with investments in scientific research.

CONTACT: Katy Lenard, klenard@burness.com, +1 301-280-5719