Priftin Approved by FDA for Latent Tuberculosis Infection Treatment

The FDA today approved a new indication for rifapentine (Priftin) in combination with isoniazid (INH) for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 and older at high risk of TB.

A New England Journal of Medicine study on LTBI revealed more patients completed the 12-dose once-weekly regimen of directly observed Priftin and INH than 9 months of daily self-administered INH, according to a press release from Sanofi. TB developed in 5 of 3074 patents taking both drugs, compared with 10 of 3074 patients who only took INH, according to Sanofi.

"Today's approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with the US Centers for Disease Control to study new opportunities to treat latent TB infection," said Paul Chew, MD, Sanofi’s global chief medical officer, in a press release. "The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century."

Priftin, an antimycobacterial used in combination with 1 or more antituberculosis drugs for the treatment of active pulmonary TB, is currently only available in the United States.

Last year, 9 million people around the world became sick with TB, and 1.5 million died from the disease, according to the World Health Organization.