FDA approves Priftin tablets to treat latent tuberculosis infection

December 2, 2014

Following a priority review designation, FDA has approved rifapentine (Priftin, Sanofi) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 years and older at high risk of progression to tuberculosis (TB) disease.

Following a priority review designation, FDA has approved rifapentine (Priftin, Sanofi) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 years and older at high risk of progression to tuberculosis (TB) disease.

Rifapentine is an antimycobacterial that has been approved since 1998, in combination with 1 or more antituberculosis drugs, for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.

“The FDA approval of rifapentine [Priftin] can be viewed as another landmark step in the development of preventative treatment, which is of particular important in younger population,” according to FormularyWatch Advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

The new approval for Priftin was based in part on the PREVENT TB study conducted by the CDC-Tuberculosis Trials Consortium (TBTC) and published in the New England Journal of Medicine in 2011. The PREVENT TB study compared a 12-week, once-weekly regimen of Priftin plus INH (3RPT/INH), using Direct Observation Therapy, with 9 months of self-administered daily INH (9INH).

Tuberculosis disease developed in 5 of 3,074 randomized patients in the 3RPT/INH group (cumulative rate, 0.16%) versus 10 of 3,074 patients in 9INH group (cumulative rate, 0.32%), for a difference in cumulative rates of 0.17%, 95% CI (-0.43, 0.09). The proportion of patients completing treatment was 81.2% in the 3RPT/INH group and 68.3% in the 9INH group for a difference (3RPT/INH-9INH) of 12.8%, 95% CI (10.7, 15.0). Sanofi provided support for the CDC-TBTC study in the form of Priftin drug supply.

Following the trial, CDC updated its treatment guidelines for LTBI to recommend the 12-dose Priftin-INH combination as an equal alternative to 9 months of daily INH. In addition, WHO Guidelines on the management of latent tuberculosis infection released in October 2014 now recommend a 12-week regimen of weekly rifapentine plus INH as a treatment option.

“Sanofi is one of the few companies continuing to invest in drug treatments for TB,” said John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries. “Sanofi's decision to continue investing has resulted in the approval of Priftin for a new indication which the company hopes will continue to be a market leader.”

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