Prioritised FDA review of first new TB drug in over 50 years – but SA TB patients still denied treatment
Cape Town, 18 September 2012 — Médecins Sans Frontières welcomes the decision by the US public health and drug regulator, the Food and Drug Administration (FDA) to prioritise a review of the promising new drug, bedaquiline, to treat patients with drug-resistant (DR-TB) and multi-drug-resistant tuberculosis (MDR-TB). However, the recent FDA approval does not mean that the drug will be available to South African patients.
South Africa faces a burgeoning drug-resistant TB epidemic with an estimated 13,000 cases of MDR-TB each year. At best, only a half of patients with MDR-TB are cured with existing drugs. Because of this urgent need for new drugs in South Africa, MSF strongly urges Janssen, the pharmaceutical company which produces bedaquiline, to urgently submit an application for approval to the Medicines Control Council (MCC) in South Africa. MSF also seeks a commitment from the MCC that it will similarly fast-track the review process in order to make this life-saving drug available to those who desperately need it.
To date, only a few patients in South Africa have been able to access bedaquiline through the clinical trials being conducted in this country. Bedaquiline is already available to MDR-TB patients with few other treatment options in several other countries with very stringent regulations on drug safety – including France and the UK, through “expanded access” or “compassionate use” criteria. The MCC initially approved such access in 2011, but subsequently withdrew its approval. None of the patients who would have benefited from the drug have received it. Most have subsequently died.
Delays in approving bedaquiline for local use among DR-TB patients with few other treatment options persist due to protracted negotiations between the South African Department of Health (DOH) and the MCC and despite several calls for urgent action.
On 11 April 2012, the Global Tuberculosis Community Advisory Board, Southern African HIV Clinicians' Society, AIDS & Rights Alliance for Southern Africa and Treatment Action Campaign wrote a public letter to the Minister of Health and the MCC highlighting the urgent need for expanded access to bedaquiline for patients with extensively drug-resistant TB (XDR) and pre-XDR-TB in South Africa. On 12 April 2012 MSF, the Southern African HIV Clinicians' Society and scores of concerned healthcare workers sent yet another public letter to the MCC calling for expanded access to bedaquiline for DR-TB in South Africa.
The MCC responded by requesting the DOH to submit a clinical trial protocol – adding yet another hurdle to patients getting bedaquiline.
“It is irresponsible for the DOH and MCC continue delaying expanded access to bedaquiline. Already having such severely limited treatment options these patients should not be denied access without adequate explanation. In the US just 109 MDR-TB cases were reported in 2010, and yet the FDA is fast-tracking their review of bedaquiline. Surely, in South Africa the sheer magnitude of the MDR-TB epidemic alone warrants renewed commitment from the DOH and the MCC to prevent more lives falling victim to inaction,” says MSF epidemiologist Dr Helen Cox.