Sanofi announced today that following a priority review, the U.S. Food and Drug Administration has approved Priftin (rifapentine) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease. Approved in the United States since 1998, Priftin is an antimycobacterial used in combination with one or more antituberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.
A pivotal study published in the New England Journal of Medicine on LTBI showed that more patients completed the 12-dose, once-weekly regimen of directly observed rifapentine and INH than 9 months of daily self-administered INH.
For more details, go to: http://en.sanofi.com/Images/37707_20141202_priftin_en.pdf