FDA Grants Priority Review to J&J’s Bedaquiline Tuberculosis Treatment - WSJ.com
The U.S. Food and Drug Administration approved Johnson & Johnson’s (JNJ) drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally.
The drug, Sirturo, will treat patients with multidrug resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people world-wide who can’t be cured with existing therapies alone. Tuberculosis is a bacterial infection that mostly involves the lungs.
Sirturo, also known as bedaquiline, is not expected to be a large moneymaker for Johnson & Johnson, one of the world’s largest health-care conglomerate, because the disease is prevalent in poorer countries unable to afford high prices for the treatment. Providing the drug, though, could help the company create goodwill among regulators, governments and patients around the world.
“The commercial opportunity is very limited,” said Pamela Van Houten, a J&J spokesperson. “This is part of our commitment to advance innovative medicines that help address serious public health issues.”