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news.The US Food and Drug Administration (FDA) has approved Sanofi's Priftin (rifapentine), an antimycobacterial, in combination with isoniazid (INH) for a new indication to treat latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease.
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Since 1998, Priftin has been approved in combination with one or more antituberculosis drugs, to treat active pulmonary TB caused by Mycobacterium tuberculosis.
The approval was based in part on the PREVENT TB trial conducted by the CDC-Tuberculosis Trials Consortium (TBTC).
The trial compared a 12-week, once-weekly regimen of Priftin plus INH (3RPT/INH), using Direct Observation Therapy, with nine months of self-administered daily INH (9INH).
Sanofi global chief medical officer Paul Chew said: "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.
"The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century."
After the trial, CDC updated its treatment guidelines for LTBI to recommend the 12-dose Priftin-INH combination as an equal alternative to nine months of daily INH.
Priftin is indicated in adults and children 12 years and older to treat active pulmonary tuberculosis caused by Mycobacterium tuberculosis.