Sanofi announced that following a priority review, the US Food and Drug Administration has approved Priftin (rifapentine) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease.
Approved in the United States since 1998,Priftin is an antimycobacterial used in combination with one or more antituberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis. A pivotal study published in the New England Journal of Medicine on LTBI showed that more patients completed the 12-dose, once-weekly regimen of directly observed rifapentine and INH than 9 months of daily self-administered INH.3“Today’s approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with the US Centres for Disease Control to study new opportunities to treat latent TB infection,” said Paul Chew, MD, Sanofi global chief medical officer. “The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”Sanofi is one of the few companies continuing to invest in the management of TB.Since the late 1950’s, the company has been committed to research and develop methods to treat, diagnose and prevent the disease.
According to the World Health Organization (WHO), tuberculosis is second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent. In 2013, 9 million people globally fell ill with TB,and 1.5 million died from the disease.
“The WHO’s‘End TB’ strategy-approved by the World Health Assembly in May 2014-recommends management of LTBI in people with a high risk of developing active TB, depending on the local epidemiology of the disease, says Mario Raviglione, MD, Director of the Global TB Programme, WHO.“ The new WHO Guidelines on LTBI management provide guidance on the intervention.”
Currently,Priftin is only available in the United States, and Sanofi is exploring the potential for regulatory approvals in other countries.Priftin is manufactured by Sanofi in Brindisi and Anagni,Italy.
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 3074 randomised patients in the 3RPT/INH group(cumulative rate, 0.16 per cent) versus 10 of 3074 patients in 9INH group (cumulative rate, 0.32 per cent), for a difference in cumulative rates of 0.17 per cent, 95 per cent CI (-0.43, 0.09). The proportion of patients completing treatment was 81.2 per cent in the 3RPT/INH group and 68.3 per cent in the 9 INH group for a difference (3RPT/INH-9INH) of 12.8 per cent, 95 per cent 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 nine 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.US.