French drug maker Sanofi (SNYNF.PK, SNY) Tuesday said it has received approval from the U.S. Food and Drug Administration for its Priftin (rifapentine) tablets to treat latent tuberculosis infection, or LTBI.
Following a priority review, FDA has approved Priftin in combination with isoniazid, or INH, for a new indication for treatment of LTBI in patients two years of age and older at high risk of progression to tuberculosis or TB disease.
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."
According to the firm, Priftin must always be used in combination with INH as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection, while Priftin in combination with INH is not recommended for individuals presumed to be exposed to rifamycin- or - INH resistant M. 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.
"The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century," Chew said.
Currently, Priftin is only available in the U.S. Sanofi said it is exploring the potential for regulatory approvals in other countries. Priftin is manufactured by Sanofi in Brindisi and Anagni, Italy.
Priftin, approved in the U.S., 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.
Priftin is indicated in adults and children 12 years and older for treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis. Priftin must always be used in combination with one or more antituberculosis drugs to which the isolate is susceptible, the company said.
In Paris, Sanofi shares closed Monday's trading at 78.38 euros, up 0.67 percent.
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