FDA Approves Sanofi’s TB Treatment Priftin

The FDA has approved a new indication for Sanofi’s tuberculosis drug Priftin in combination with isoniazid to treat latent tuberculosis infection (LTBI).

The approval clears the Priftin (rifapentine)-isoniazid product for use in LTBI patients who are at least two years old and at high risk of progressing to TB disease. Roughly 5 percent to 10 percent of the 11 million people in the U.S. with LTBI will develop the disease if not treated, according to the Centers for Disease Control and Prevention.

Approval was based in part on a study that compared a 12-week, once-weekly regimen of Priftin plus isoniazid with nine months of self-administered daily isoniazid only. Following the trial, the CDC updated its treatment guidelines for LTBI to recommend the 12-dose Priftin-isoniazid combination as an equal alternative to nine months of daily isoniazid.

Sanofi worked with the CDC to study new opportunities to treat LTBI, an unmet public health challenge, said Paul Chew, the company’s global chief medical officer. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.