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European Regulator Clears Two Drugs for Resistant TB

The European Medicines Agency approved two medicines to treat the multidrug-resistant form of tuberculosis, which afflicts about 1 in 20 people with the ailment, the world’s second-deadliest infectious disease.

The EMA recommended that Otsuka Holdings Co.’s Deltyba be conditionally approved for pulmonary infections due to resistant TB in adults and Lucane Pharma SAS’s para-aminosalicylic acid be approved for resistant TB in adults and children. The regulator said Deltyba’s benefits outweigh its risks and that its approval depends on Otsuka undertaking additional tests of the medicine’s long-term effectiveness.

“Multidrug-resistant tuberculosis is associated with a very high mortality rate and poses a significant public-health threat as individuals infected with drug-resistant strains are unable to receive adequate treatment and can potentially spread their infection,” EMA said in a statement on its website.

About 450,000 people a year contract multidrug resistant TB around the world, according to EMA. MDR-TB is defined as tuberculosis which doesn’t respond to isoniazid and rifampicin, two drugs that are standard therapies for TB. Much of the disease burden is in developing countries, and in Europe TB struck about 2.3 in every 10,000 people in 2011, EMA said.

Tuberculosis, the world’s deadliest infectious disease after AIDS, killed 1.4 million people in 2011, according to the World Health Organization.

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