Makers of an investigational tuberculosis drug that has been urged for “compassionate use” approval in South Africa have applied to the European Medicines Agency to market the medicine as part of a combination therapy for multidrug-resistant tuberculosis.
“If approved, bedaquiline could be one of the first drugs with a new mechanism of action for tuberculosis in more than 40 years and one of the first ever to be specifically indicated for MDR-TB,” a release from drug maker Janssen-Cilag International said. Janssen also submitted an application for bedaquiline to the U.S. Food and Drug Administration in June.
Delamanid, another drug with a new approach to tuberculosis, was submitted by drug maker Otsuka to the EMA for approval in late 2011.
“If these drugs are approved it will be really good news for drug resistant tuberculosis,” Erica Lessem, assistant director of Treatment Action Group’s TB/HIV Project said. “Hypothetically, no one should have any resistance to either drug.”
The news of this step forward for bedaquiline — also known as TMC207 — comes the same week as a Lancet article that examined challengingly high levels of multidrug-resistant tuberculosis that threaten the continued viability of existing treatments across eight countries, including South Africa.
Treatment Action Group, along with Medecins Sans Frontieres (MSF, or Doctors without Borders), the Global TB Community Advisory Board and other advocates wrote to South Africa’s Medicines Control Council in April urging bedaquiline be available for “compassionate use” — a conditional program in which a drug still under investigation is made available to patients with whom other treatment has been unsuccessful. South Africa is home to one of the highest prevalences of multidrug-resistant tuberculosis in the world.
Bedaquiline is available for compassionate use in other countries, Lessem said, adding that Otsuka has not yet made delamanid available for that use.
Once the drugs are approved, they likely will be used together, Lessem said, pointing to the importance of gathering information on how the drugs will interact.
Marketing approval through the EMA is a lengthy process that could take more than a year, so allowing for earlier acccess through compassionate use to these new compounds could be life-saving for TB patients with no other effective treatment options, Lessem said.