WASHINGTON – Johnson & Johnson has won accelerated Food and Drug Administration approval for its tuberculosis tablet Sirturo, the first medicine in 40 years that provides a new way to treat the contagious lung infection.
The FDA cleared Sirturo to be added to existing therapies for use by adults whose illness is resistant to multiple drugs, J&J said Monday in a statement. The FDA cleared Sirturo based on the second of what are typically three clinical trial phases, an option the agency has when a drug treats a serious disease and fills an unmet need.
There were 8.7 million new cases worldwide of tuberculosis in 2011, with multidrug-resistant forms accounting for as many as 400,000 cases, according to a World Health Organization report. The international charity Doctors Without Borders called approval of Sirturo an immense milestone, and FDA Commissioner Margaret Hamburg said the drug adds a new weapon to the arsenal for fighting this deadly, contagious disease.
The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer, said Dr. Manica Balasegaram, of the Doctors Without Borders Access Campaign.
Most drug-resistant cases occur in China, India, the Russian Federation and South Africa, according to the WHO. While tuberculosis was once the leading cause of death in the U.S., the drug-resistant version of the illness affected about 98 people in the nation last year, according to the Centers for Disease Control and Prevention.
Finding a treatment for tuberculosis was the passion of Paul Janssen, founder of J&J unit Janssen Pharmaceutica, whose sister died of the disease, said Paul Stoffels, J&Js chief science officer and worldwide chairman of its pharmaceuticals group. U.S. approval will help gain clearance in other countries where the disease is more of a burden, he said.
J&J, based in New Brunswick, N.J., is the parent of Warsaw-based DePuy Synthes Co.