The approval by the US Food and Drug Administration of an important new tuberculosis treatment must lead to its availability in countries with high levels of the drug-resistant form of the deadly disease.
NEW YORK/GENEVA, December 31, 2012 — The approval by the US Food and Drug Administration of an important new tuberculosis treatment must lead to its availability in countries with high levels of the drug-resistant form of the deadly disease, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) said today.
The new drug, bedaquiline, is the first active agent against tuberculosis to be registered since 1963, and its approval was welcomed by MSF as it marks a major improvement in combating the most challenging forms of TB, which require complex regimes often accompanied by pronounced side effects.
“The first new drug to treat TB in 50 years is an immense milestone,” said Dr. Manica Balasegaram, executive director of the MSF Access Campaign. “The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer.”
Today’s treatment for multidrug-resistant TB (MDR-TB) consists of a two-year course of up to 20 different pills that must be ingested every day, combined with roughly eight months of daily injections. Patients are subjected to excruciating side effects, ranging from permanent deafness and persistent nausea, to psychosis. Globally, only 48 percent of people who begin treatment for DR-TB are cured. The cure rate in MSF treatment programs is slightly better at 53 percent, but still unacceptably low.
“Ministries of health and drug regulators need to work together to make sure people with MDR-TB benefit from this important medical advance as soon as possible,” said Dr. Balasegaram. “The onus is on all of us to use bedaquiline to devise new treatment regimens for drug-resistant TB that are shorter, more tolerable for patients, and more effective. With better treatment on the way, there should be all the more incentive to scale up our efforts to treat MDR-TB today.”
The scale of the DR-TB epidemic is huge, with 310,000 new cases reported in 2011. Globally, however, only 19 percent of people thought to be infected are receiving treatment.
“Scale-up of global DR-TB treatment has remained shockingly low, to a large degree because the current treatment regimen is so complex and costly for health programs and difficult to tolerate for patients,” said Dr Francis Varaine, leader of MSF’s TB Working Group. "With simpler, shorter and more effective treatment regimens, we will be able to scale-up treatment and cure more people with DR-TB."
In addition to bedaquiline, developed by Janssen, a second new drug that is active against MDR-TB called delamanid, developed by Otsuka, is undergoing registration by the European Medicines Agency and is expected to be approved for use in 2013. Together, the two new drugs represent an unprecedented opportunity to improve treatment for MDR-TB. Ensuring the drugs are combined and introduced in the most effective manner is extremely urgent.
Access to the new drugs will depend to a large degree on the manufacturers, MSF said. The companies should make the drugs available for research in order to develop shorter, more effective regimens, to register them in high-burden countries as quickly as possible once they have been approved, and to ensure they are affordable in countries where they are needed most.
MSF treated 26,600 TB patients in 36 countries in 2011, 1,300 of whom had drug-resistant forms of the disease.