The Médecins Sans Frontières (MSF) has called upon the Union health ministry and the drug regulators in the country to work together to ensure that multi-drug resistant TB (MDR-TB) patients, who are left with few options, benefit from new TB drug bedaquiline, which has been approved by the US FDA for the first time since 1963.
Welcoming the approval of bedaquiline by the US FDA, the first new drug active against TB to be registered since 1963, executive director of the MSF Access Campaign Dr Manica Balasegaram said, "The first new drug to treat TB in 50 years is an immense milestone. The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer."
Calling for rapid registration of the new drug in countries with high drug-resistant tuberculosis burden, the international humanitarian organisation said that the Indian drug authorities should work hard to make sure that people with MDR-TB benefit from this important medical advance as soon as possible. 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 are more effective, it said.
India has the second highest MDR TB burden in the world with nearly 66,000 new cases every year. This new drug comes at a time when the MDR-TB patients desperately need more options. Current treatment for MDR-TB is a 2-year course of up to 20 different pills per day and around eight months of daily injections. Patients are subjected to excruciating side effects, ranging from permanent deafness and persistent nausea to psychosis.
"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 programmes 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, and ensuring the drugs are combined and introduced in the most effective manner is extremely urgent.
But access to the new drugs will depend to a large degree on the manufacturers. MSF has called upon the manufacturers to 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.