FDA Approves J&j Tablet for Tuberculosis Sirturo the First New Treatment for Tb in 40 Years
Edney, Anna, Pittsburgh Post-Gazette (Pittsburgh, PA)
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, New Brunswick, N.J.-based 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," Manica Balasegaram, executive director of the Doctors Without Borders Access Campaign, said in an emailed statement.
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&J's 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, Mr. …