Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Priftin (rifapentine) in combination with isoniazid (INH) as treatment for latent tuberculosis infection (LTBI) in patients two years old and above who are also at high risk of developing tuberculosis (TB).
Priftin is an antimycobacterial used as combination therapy together with other anti-TB drugs for the treatment of active pulmonary tuberculosis resulting from Mycobacterium tuberculosis. The drug initially received approval from the FDA in 1998.
The new approval was supported by positive study results published in the New England Journal of Medicine, which showed that more patients completed the 12-dose, once weekly regimen of Priftin and INH than 9 months of daily INH administered by the patients themselves.
Paul Chew, Sanofi Global CMO, said, “Today’s approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with the U.S. Centers for Disease Control to study new opportunities to treat latent TB infection.” He added that the newly approved indication for Priftin shows the company’s commitment to finding treatments for TB, which remains a significant cause of death worldwide.
Tuberculosis comes next only to HIV/AIDS as the world’s greatest killer due to a single infectious agent. Last year, 9 million people were afflicted with TB, with 1.5 million lives lost to the disease. Those with latent TB infection and are at a high risk of progression to TB include those in close contact with active TB patients, recent converts to a positive tuberculin skin test, those with pulmonary fibrosis on radiograph, and HIV-infected patients.
“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,” said Mario Raviglione, director of the Global TB Programme at WHO.
Sanofi said it is studying Priftin’s potential for authorization in other countries aside from the U.S., where it is currently exclusively available.