Magazine Article | January 31, 2013

FDA Incentives Could Pay Dividends For J&J

To access this content, please Register or Sign In.

In January, the FDA approved Sirturo, a drug developed by J&J (NYSE: JNJ) to treat multidrug resistant tuberculosis (MDR-TB). What makes this announcement particularly interesting isn’t the fact that Sirturo is the first new drug in 40 years to be approved to treat tuberculosis. What makes it interesting is the fact that J&J targeted the United States for approval, when fewer than 100 Americans have this potentially fatal disease. Even more interesting is the fact that the drug was granted accelerated approval based on data from a pair of Phase 2 studies.