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. Priftin is an antimycobacterial that has been approved since 1998, in combination with one or more antituberculosis drugs, for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.

A person with LTBI is infected with the bacteria that cause TB, but does not feel sick, have symptoms, and cannot spread the bacteria to others. More than 11 million people living in the United States have LTBI, and about five to 10 percent of those – up to more than 1 million people – will develop TB disease if not treated. Treatment for LTBI in patients at risk of progression greatly reduces the risk that TB infection will progress to TB disease.

“For people at high risk for progressing to active TB, treating LTBI is an important public health strategy for tuberculosis control,” said Robert Belknap, M.D., director, Denver Metro Tuberculosis Control Program at Denver Public Health and past-president of the National Society of TB Clinicians. “A study published in the New England Journal of Medicine 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.” Sanofi is one of the few companies continuing to invest in the management of TB infection. Since the late 1950’s, the company has been committed to research and develop methods to treat, diagnose and prevent the disease.

“Today’s approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with CDC to study new opportunities to treat latent TB infection,” said Paul Chew, M.D., Sanofi Global Chief Medical Officer.

“The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”