Sanofi SA (ADR) (NYSE:SNY) announced before US markets opened for trading Tuesday that the US Food and Drug Administration (FDA) has approved its Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection.
The FDA, following a priority review, has approved Priftin, to be used in combination with isoniazid, for the new indication. The drug, first approved for sale in the US in 1998 to treat active pulmonary tuberculosis, can now be administered to patients over 2 years of age at high risk of developing the disease.
Sanofi said that Priftin must always be used in conjunction with isoniazid as a 12-week once-a-week treatment for latent tuberculosis infection. The only sign that a person is infected with the disease is that of a positive reaction to the TB skin or blood test. Without treatment, however, about 5-10% of those infected with latent tuberculosis infection will go on to develop TB at some point in their lives, with about 50% of these incidences occurring within the first two years of infection. The World Health Organization (WHO) estimates that 9 million people fell sick with TB in 2013, with 1.5 million people dying from the disease in the same year.
Paul Chew, Sanofi Global Chief Medical Officer, stated: “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. The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”