LONDON Nov 22 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
"Multidrug-resistant tuberculosis is associated with a very
high mortality rate," the London-based agency said in a
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
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
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.