Stop TB Partnership

First time in decades: New antibiotic to treat Multidrug-Resistant Tuberculosis (MDR-TB) receives approval in Peru

29 January 2015 -- Lima, Peru - Pulmonary multidrug-resistant tuberculosis (MDR-TB) causes the deaths of over 200,000 people globally each year. With an estimated 2,000 cases in 2013, Peru has the highest prevalence of MDR-TB in Latin America and the Caribbean and cases have significantly increased since 2009 . On December 13th 2014, Janssen, the pharmaceutical affiliate of Johnson & Johnson, received approval for SIRTURO® (bedaquiline) from the Peruvian health authorities.

"We at Janssen Global Public Health are delighted that SIRTURO® has been approved for use in Peru given the significant public health threat MDR-TB poses in the country," said Tomas Matthews, Global Access Director, Janssen Global Public Health. "The approval represents critical progress toward controlling this disease in the Latin America region, given that Peru is home to the highest number of MDR-TB patients in the region."

This new approval marks the first such authorization for SIRTURO® in Latin America and the Caribbean and presents the country with the first new specific treatment for MDR-TB to be launched in several decades. SIRTURO® will now be available for use in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. SIRTURO® was discovered by scientists at Janssen and has a unique mechanism of action that inhibits mycobacterial adenosine 5'-triphosphate (ATP) synthase, an enzyme that is essential for power generation in Mycobacterium tuberculosis.

Access to SIRTURO® in Peru will be facilitated through a collaboration between Janssen and the Stichting International Dispensary Association (IDA) and the Global Drugs Facility (GDF) of the Stop TB Partnership supported by the World Health Organization (WHO) regional office for the Americas.

SIRTURO® is already approved in the United States, European Union, South Korea, South Africa, India and the Russian Federation. There have also been regulatory submissions in China, Thailand, Vietnam, Colombia and Kazakhstan.