Tuberculosis is a highly infectious disease that is transmitted through the air and usually affects the lungs but can also affect other parts of the body, including the brain and kidneys. It is considered one of the world’s most serious public health threats. Multidrug-resistant tuberculosis is a growing problem in the world, especially in poorer countries. About 12 million people worldwide had tuberculosis in 2011, according to Johnson & Johnson, and about 630,000 had multidrug-resistant TB.
The Food and Drug Administration announced recently that it had approved a new treatment for multidrug-resistant tuberculosis that can be cautiously used as an alternative when other drugs fail.
The drug (Sirturo) was discovered by scientists at Janssen, thepharmaceuticals unit of Johnson & Johnson, and is the first in a new class of drugs that aims to treat the drug-resistant strain of the disease.
Word of Caution:
Although Sirturo was approved, the F.D.A. also issued some words of caution.
“Multidrug-resistant tuberculosis poses a serious health threat throughout the world, and
– Sirturo provides much-needed treatment for patients who don’t have other therapeutic options available.”
– “Because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.”
The consumer advocacy group Public Citizen opposed approval in a letter to the F.D.A. in mid-December, saying that the results of a limited clinical trial showed that patients using bedaquiline were five times as likely to die than those on the standard drug regimen to treat the disease.
Jan Gheuens, interim director of the TB Program for the Gates Foundation, called it a “long-awaited event” and said the fight against TB had not benefited from new drugs in the way H.I.V. had. Beyond the benefits of the drug itself, he said the quick approval process could be a model for other drugs sorely needed in the developing world.
He also suggested, however, that more trials should be conducted to get a better understanding of the side effects that led to the black box warning.
- Resistant Tuberculosis Drug Sirturo (bedaquiline) Approved By FDA (medicalnewstoday.com)
- 1st New Tuberculosis Drug in 40 Years (abcnews.go.com)
- FDA approves 1st new tuberculosis drug in 40 years (thenewstribune.com)
- Tuberculosis tablet approved by FDA (sfgate.com)
- FDA approves 1st new tuberculosis drug in 40 years (kansascity.com)
- Multidrug and Extensively Drug-resistant Tuberculosis in Canada 1997 – 2008: Demographic and Disease Characteristics (plosone.org)