While it was revealed recently that the United States and European drug regulators are pulling out all the stops to register bedaquiline, or TMC207, the South African Medicines Control Council (MCC) has shown no intention of following suit, according to Médecins Sans Frontières (MSF).

Many other countries with stringent regulations on drug safety – including France and the United Kingdom – are already providing bedaquiline under compassionate use regulations, despite the fact that they have far less patients.

MSF earlier sought commitment from the MCC to allow expanded access to the drug and hope that they will similarly fast-track the review process which could see the registration of the first new TB drug in over 50 years.

‘€œWhile MSF awaits registration of bedaquiline in South Africa and therefore broader access, access to this life-saving drug for patients with few other treatment options should not be denied without adequate explanation. As the Department of Health and the MCC prolong their decision on expanded access to bedaquiline, patients with drug resistant tuberculosis in need of the drug are dying,’€ the humanitarian group said in a statement.

The MCC, while initially giving approval for compassionate access in 2011, subsequently withdrew approval, and none of the patients who would have benefited from the drug have received it. Most have subsequently died.

Compassionate use allows for the dispensing of investigational drugs before they are registered and enter the market. MSF and other organisations around the world have attempted to use bedaquiline for a select few patients with pre-extensively drug resistant and multi-drug resistant TB. For many of these patients there is no other hope and bedaquiline offers a last chance of survival.

‘€œTo date, only a very few patients in South Africa have been able to access bedaquiline through the clinical trials that were and are being conducted in this country. This is despite a number of patients from other countries, in whom current treatment is unlikely to be effective, accessing the drug through ‘expanded access’ or ‘compassionate use’ criteria,’€ MSF pointed out in statement.

Delays in MCC approval for this promising new drug comes despite appeals from civil society and health organisations to ensure that bedaquiline be made available for DR-TB patients with limited options.

In April this year, the Global Tuberculosis Community Advisory Board, the Southern African HIV Clinicians’ Society, The AIDS & Rights Alliance for Southern Africa and the Treatment Action Campaign wrote a public letter to the Minister of Health and the MCC to highlight the urgent need for compassionate use of bedaquiline in South Africa.

This was followed by another public letter to the MCC by MSF, The Southern African HIV Clinicians’ Society and dozens of concerned health care workers, calling for compassionate use of bedaquiline for DR TB in South Africa.

The MCC responded by requesting the health department to submit a clinical trial protocol, adding another hurdle to access of bedaquiline.

‘€œThe hands-off attitude of the MCC paints a sad contrast with the proactive approach of the US Food and Drug Administration. When one compares the burden of MDR TB in both countries, the delays of the health department and MCC seem even more irresponsible: in 2010, 109 cases of multi-drug resistant (MDR) TB were reported in the US, compared to 7 386 in South Africa. The magnitude of the MDR-TB epidemic warrants renewed commitment; too many lives fall victim to inaction,’€ MSF said.
According to MSF it did receive approval from the MCC in August last year to use the drug on compassionate grounds, but the manufacturer Janssen Pharmaceuticals (formerly Tibotec) was verbally informed by the MCC to not give MSF TMC207.

South Africa has a serious epidemic of DR TB ‘€“ Every year about 10 000 people are diagnosed with MDR TB, with a substantial proportion developing extensively drug resistant (XDR) TB.

Under the best circumstances, treatment with current, mostly very old drugs is only successful for around 60 percent of MDR TB and 44 percent of XDR TB patients.

The FDA aims to decide whether to approve the drug within six months of the application of the submission, rather than the standard 10 months. The European Medicines Agency is currently considering conditional approval for the use of the drug.