Additional proof that not-for-profit drug development offers a way forward for neglected patients

The Drugs for Neglected Diseases initiative (DNDi) congratulates TB Alliance and its partners on receiving approval from the U.S. Food and Drug Administration (FDA) for pretomanid for the treatment of highly drug-resistant forms of TB. Pretomanid is only the third new anti-TB drug approved for use by FDA in more than 40 years, and has now been approved as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB).

“This new drug and the associated new drug regimen from the TB Alliance ushers in a long-due transformation of multi drug resistant TB treatment,” said Bernard Pécoul, Executive Director of DNDi. “Now ensuring access is essential. The new regimen should be incorporated into the TB programs without delay.”

Pretomanid is also the first tuberculosis drug to be developed and registered by a not-for-profit organization. “TB Alliance has offered the global health community more proof that the non-profit product development model can fill the gap in essential health tools for neglected patients,” added Dr Pécoul.