Statement |

MSF reaction to US FDA's decision granting priority review to first new TB drug in 50 years

3 min

First new TB drug in over 50 years presents the opportunity to truly change today’s DR-TB treatment regimen and improve outcomes, while making treatment more tolerable for patients

Drug-resistant TB (DR-TB) is a growing public health emergency, with near half a million new cases globally each year, and 150,000 annual deaths. The treatment available today involves up to two years of taking multiple medicines that can have serious side effects, some as bad as psychosis and deafness. And the cure rate is approximately 65%. While there has been little movement on the development of new drugs for TB in over half a century, two new drugs that could be active against DR-TB are on the horizon. The one is bedaquiline (formerly known as TMC-207, submitted for FDA approval by Janssen Pharmaceuticals/ Johnson&Johnson) and the other is delaminid (formerly known as OPC-67683, submitted for European Medicines Agency approval by Japanese pharmaceutical company Otsuka).

The US Food and Drug Administration (FDA) has just granted ‘priority review’ for one of these drugs, bedaquiline. A priority review is granted when a drug offers a potential major advance in a disease area where the current therapy is lacking — here, acknowledging the poor outcomes seen with the current DR-TB treatment. This priority review means that potentially within the next six months, a completely new compound to treat DR-TB could be available. It is still unknown what role bedaquiline will play to strengthen and improve the existing DR-TB treatment regimen, and this needs to be addressed urgently. In the meantime, while bedaquiline’s exact role is defined, there needs to be advice on how best to use it to avoid resistance being generated to this major advance in DR-TB care.

“It’s extremely exciting news that finally after more than fifty years, there will soon be a totally new drug to treat tuberculosis that will work in people with deadly drug-resistant forms of the disease. This drug could help beat back the growing DR-TB emergency, and improve the lives of patients who today must tolerate treatment that lasts up to two years with drugs that cause side effects ranging from psychosis to deafness, with no guarantee of cure. What needs to be figured out urgently is how this new drug can be used to maximise its potential, while ensuring it is not used in a way that could create resistance, which would be catastrophic. This new drug must also be made affordable in developing countries, where the vast majority of people with drug-resistant forms of TB live.”  

— Dr Grania Brigden, TB Advisor, Médecins Sans Frontières Access Campaign