FDA approves Sanofi’s Priftin for latent TB

3 December 2014

French pharma major Sanofi (Euronext: SAN) says that 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 aged two years and older at high risk of progression to TB disease.

Patients at high-risk include: HIV-infected patients, those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, or those with pulmonary fibrosis on radiograph.Priftin, developed by legacy company Hoechst Mariona Rouddrl, was previously available only for active TB disease (approved in 1998), and now it has a new indication for people with latent TB. Even though Priftin no longer has patent exclusivity, Sanofi felt that investing in its further development was the right thing to do, and has been researching and working on TB for more than 50 years, the company said.

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 US Centers for Disease Control to study new opportunities to treat latent TB infection."

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