FDA approves Priftin + Nydrazid for treatment of latent Tuberculosis Infection- Sanofi

Sanofi has announced that following a priority review, the FDA has approved Priftin (rifapentine) in combination with Nydrazid (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. Approved in the United States since 1998, Priftin is an anti-mycobacterial used in combination with one or more anti-tuberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium 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. Sanofi is one of the few companies continuing to invest in the management of TB. Since the late 1950s, the company has been committed to research and develop methods to treat, diagnose and prevent the disease.

Currently, Priftin is only available in the United States, and Sanofi is exploring the potential for regulatory approvals in other countries.