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Sanofi announces the US FDA's approval for Priftin in combination with isoniazid (INH) for treating latent tuberculosis infection.

M2 EQUITYBITES-December 3, 2014-Sanofi announces the US FDA's approval for Priftin in combination with isoniazid (INH) for treating latent tuberculosis infection


Healthcare company Sanofi (NYSE:SNY) on Tuesday reported the approval of Priftin 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 following a priority review by the US Food and Drug Administration.

The company said Priftin (rifapentine) is an antimycobacterial that has been approved in combination with one or more antituberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.

According to the company, a person with LTBI is infected with the bacteria that cause TB, but does not feel sick, have symptoms and cannot spread the bacteria to others. The treatment for LTBI in patients at risk of progression greatly reduces the risk that TB infection will progress to TB disease.

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

In conjunction with the CDC-TBTC study, Sanofi provided support in the form of Priftin drug supply.

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Publication:M2 EquityBites (EQB)
Date:Dec 3, 2014
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