Priftin Gains Latent TB Infection Indication
Sanofi announced that the Food and Drug Administration (FDA) has approved Priftin (rifapentine) in combination with isoniazid for the treatment of latent tuberculosis infection in patients aged ≥2 years at high risk of progression to tuberculosis disease.
The FDA approval was based on the PREVENT TB Study conducted by the Centers for Disease Control - Tuberculosis Trials Consortium (TBTC) in 2011. The study assessed a 12-week, once-weekly regimen of Prfitin plus isoniazid, using direct observation therapy, vs. nine months of self-administered daily isoniazid. Tuberculosis disease was seen in 0.16% (5/3074) of patients in the Prfitin plus isoniazid group vs. 0.32% (10/3074) in the 9 month isoniazid group. The percent of patients completing treatment was 81.2% in the Priftin plus isoniazid vs. 68.3% in the nine month isoniazid group.
Priftin is already approved for the treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis in patients aged ≥12 years, in combination with one or more antituberculosis drugs.
Priftin is available in 150mg strength tablets in 24- and 32-count cartons.
For more information call (800) 446-6267 or visit Sanofi-Aventis.US.