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Sanofi's Priftin cleared for latent tuberculosis in the US

FDA approves Priftin with isoniazid for patients aged two years and older
Sanofi reception

Sanofi has won approval in the US to market its tuberculosis therapy Priftin for latent TB, which poses a major challenge to efforts to control the disease.

It is estimated that around one-third of the world's population has latent TB, meaning they have been infected with Mycobacterium tuberculosis but do not show symptoms and cannot transmit the disease. However, they have a lifetime risk of 5-10% for the infection re-emerging and form a reservoir for the bacterium that undermines efforts to eradicate the infection.

After a priority review, the FDA has approved Priftin (rifapentine) in combination with isoniazid to treat latent TB infection in patients aged two years and older.

Sanofi's drug was first approved to treat TB in 1998 and remains only available in the US. The company has said it intends to explore regulatory filings for the drug for latent TB in other countries.

In the PREVENT TB trial, 12 once-weekly doses of Priftin plus isoniazid given daily for nine months halved the rate of re-activated TB infections compared to isoniazid given alone.

"Reactivation of latent TB significantly contributes to the TB burden particularly in low incidence countries," according to the World Health organization (WHO), which published new guidelines on testing, treating and managing latent TB infection last month.

As the risk of re-activation is higher in those with compromised immune systems, such as people living with HIV, the guidelines recommend that systematic testing and treatment of vulnerable groups.

In addition to HIV and people exposed to active TB cases, the WHO also suggests testing of patients undergoing tumour necrosis factor (TNF) inhibitor therapy, dialysis and organ transplantation, as well as those who have silicosis of the lungs.

Five treatment options are recommended for the treatment of LTBI in the guidelines: isoniazid daily for six or nine months; the combination of Priftin and isoniazid once a week for 12 weeks; the combination of rifampicin and isoniazid daily for 3-4 months; and rifampicin monotherapy given daily for 3-4 months.

The WHO notes that TB is second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent. In 2013, nine million people globally fell ill with TB, and 1.5 million died from the disease.

Article by
Phil Taylor

2nd December 2014

From: Sales



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