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.