EU regulators back two new drugs for resistant tuberculosis

LONDON Fri Nov 22, 2013 10:51am EST

LONDON Nov 22 (Reuters) - European drug regulators gave their backing on Friday to two new medicines for multidrug-resistant tuberculosis (TB), an infectious disease that affects some 450,000 people worldwide each year and for which there are few effective treatments.

The European Medicines Agency (EMA) said its support for marketing authorisations for Otsuka's TB drug Deltyba and for Para-aminosalicylic acid Lucane, made by the privately-owned French firm Lucane Pharma, were part of efforts to tackle the growing public health challenge of antibiotic resistance.

"Multidrug-resistant tuberculosis is associated with a very high mortality rate," the London-based agency said in a statement.

These infections pose "a significant public health threat as individuals infected with drug-resistant strains are unable to receive adequate treatment and can potentially spread their infection," it added.

The Geneva-based World Health Organisation (WHO) says 8.6 million people became ill with TB in 2012, and 1.3 million people died of the disease.

With multi-drug resistant strains of the disease spread rapidly across the world, experts say there is an urgent need for new TB drugs that can be reserved for difficult-to-treat cases that do not respond to first-line treatments.

The WHO said in its latest global TB report in October that there are 10 new or re-purposed anti-TB drugs in late phases of clinical development.

Para-aminosalicylic acid, of which Para-aminosalicylic acid Lucane is a new formulation, in 1946 became the second medicine to be introduced to treat TB and was part of standard-of-care treatment until the 1970s when newer drugs took its place.

Its use resumed in the 1990s with the emergence of multidrug-resistant TB.

In 2012, Johnson & Johnson's drug Sirturo, known generically as bedaquiline, became the first new type of TB drug to win U.S. regulatory approval in more than 40 years.

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