French drug maker Sanofi (SNYNF.PK,SNY) announced Tuesday that Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection has received approval from the U.S. Food and Drug Administration.
Following a priority review, FDA has approved Priftin in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection or LTBI in patients two years of age and older at high risk of progression to tuberculosis or TB disease, the company noted.
Priftin, approved in the United States since 1998, is an antimycobacterial used in combination with one or more antituberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.
Paul Chew, Sanofi Global Chief Medical Officer, 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. The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century."
Currently, Priftin is only available in the United States. Sanofi is exploring the potential for regulatory approvals in other countries. Priftin is manufactured by Sanofi in Brindisi and Anagni, Italy.
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