FDA clears Sanofi TB drug indication
pharmafile | December 2, 2014 | News story | Research and Development, Sales and Marketing | Bedaquiline, FDA, Sanofi, WHO, priftin, rifapentine, sirturo
The FDA has approved Sanofi’s Priftin for a new tuberculosis (TB) indication following a priority review from the regulator.
Priftin (rifapentine) has been approved for the treatment of active pulmonary TB in the US since 1998. The new FDA ruling allows it to also be used in combination with isoniazid to treat latent tuberculosis infection (LTBI) in patients over two years old and with a high risk of developing the disease.
The approval follows trial results showing that more patients complete a regimen of this combination than isoniazid alone.
Paul Chew, Sanofi’s global chief medical officer says: “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. The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”
According to the World Health Organization (WHO), tuberculosis is second only to HIV/AIDS as the world’s greatest killer. Nine million people globally fell ill with TB in 2013, and 1.5 million died from the disease.
“The WHO’s ‘End TB’ strategy recommends management of LTBI in people with a high risk of developing active TB, depending on the local epidemiology of the disease,” adds Mario Raviglione, director of the global TB programme and the WHO.
Priftin has yet to be approved outside of the US, but naturally Sanofi says that it is exploring the potential for its approval in other countries.
Treatment ‘far below’ target
This is the second time TB drugs have been in the spotlight recently, and follows Janssen’s Sirturo (bedaquiline) which won the 2014 UK Prix Galien Award for being the first TB medication with a novel mechanism of action to be approved in four decades.
Earlier this year, though, a report from the European Centre for Disease Prevention and Control (ECDC) warned that European countries are still not getting to grips with the diagnosis and treatment of tuberculosis.
The study found that only seven European countries can show a mean five-year decline in multi-drug resistant (MDR) TB rates, and Europe’s overall treatment success rate for the condition ‘remains far below’ the 70% target set out in a previous action plan.
George Underwood
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