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Johnson & Johnson TB Drug Given Clearance

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The new drug, Sirturo, will help treat those patients that have Multidrug Resistant TB or MDR-TB

January 3, 2013 – The Johnson & Johnson drug to help treat a resistant form of tuberculosis was given fast track clearance by the U.S. Food and Drug Administration. The form of TB is still uncommon in the United States, but is growing around the world.

The new drug, Sirturo, will help treat those patients that have Multidrug Resistant TB or MDR-TB. The disease can be fatal and affects up to 630,000 people worldwide who cannot be cured with therapies that exist today.

Tuberculosis is an infection caused by bacteria and attacks mostly the lungs. Sirturo, also called bedaquiline, is not thought to be a big moneymaker for J&J, one of the largest healthcare conglomerates in the world, because TB is mainly prevalent in the world’s poorer nations that are unable to afford treatments that have high prices.

However, providing the new treatment could help J&J create enormous goodwill amongst regulators, patients and governments across the globe.

A spokesperson for J&J said the commercial opportunity for the drug was limited, but it was part of the company’s commitment to advance new and innovative medicines that are able to help address issues of public health that are very serious.

J&J said Sirturo should be ready to sell during the second quarter of this year and did not announce what the sales price was. Less than 100 people in the U.S. suffer from MDR-TB, according to Johnson & Johnson. However, the FDA approval will help strengthen the chances for the drug’s approval in regions of the world where the disease has become more prevalent including Eastern Europe, China and India.

Nevertheless, the drug has
potential risks that include an increased chance of death and that raised questions amongst members of the U.S. regulatory agency. A prominent warning label must be placed on the new drug that informs patients that take Sirturo that clinical trials show an increased rate of fatalities.

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