Cape Town - Patients with multidrug-resistant (MDR) tuberculosis could soon have access to a promising new drug – Bedaquiline – as the Medicines Control Council (MCC) is “fast-tracking” its authorisation processes to have the drug licensed.
If approved, it will be the first time the drug is widely distributed in this country where more than 10 000 people are diagnosed with MDR-TB every year.
The drug, which has already been approved by the Food and Drug Administration in the US, has been undergoing trials in South Africa, via a clinical access programme driven by the national Department of Health.
On Tuesday the regulatory body’s registrar, Mandisa Hela said the new drug had been granted “fast-track status” by the council.
However, she could not give exact timelines of its approval.
“Details of how far the review is cannot be divulged to anybody but the applicant in terms of section 34 of the Medicines and Related Substances Act,” she said.
At the South African TB Conference held in Durban last week, experts, including health department officials said the approval of Bedaquiline was imminent.
UCT’s head of pulmonology, Professor Keertan Dheda, said he had heard “word on the street” that Bedaquiline would be approved within weeks.
The pending approval is welcome news for most MDR-TB sufferers who have to endure a two-year course of oral and injectable drugs, with some major side effects such as permanent hearing problems.
Earlier trials showed it was safe and more effective than the current drugs used to treat MDR-TB. But the drug also carried significant risks.
The World Health Organisation (WHO) Expert Group’s evaluation of trial data from a Phase 2b trial found more deaths in the Bedaquiline phase of the trial than the placebo phase.
However, 62 percent of patients in the Bedaquiline phase were cured compared to 44 percent in the placebo phase, and sooner.
Another drug that scientists hope will soon be accessible is the generic version of Linezolid – the TB antibiotic that has successfully treated some cases of extreme drug-resistant (XDR) TB
At more than R700 for a daily pill, Linezolid, which is produced by Pfizer, remains out of reach for most South African XDR-TB patients.
International medical humanitarian group Medicins Sans Frontieres, which applied to the MCC for special section 21 permission to provide the cheaper generic, procures Linezolid for about R80 a pill.