FDA Approves New Drug for Multi-Drug Resistant Tuberculosis, Sirturo –First New Drug in 40 Years for TB
Posted Dec 31 2012 3:48pm
Amongst all the recalls Johnson and Johnson has had a good year with FDA approvals including this one as there has not bee anything new approved in years. There is an inhaled TB vaccine in the works from a few years back.
Probably more recent in the news was the “Occupy” location in Atlanta where homeless people were testing positive for TB. The new drug is pretty hefty with warnings as well and is to be used after other medications have failed and carries the black box warning as it is considered a new class of drugs and there could be more deaths attributed to it’s use. This type of TB is rare in the US but growing in other countries and TB is spread through the air. BD
The Food & Drug Administration today approved the first drug to treat multi-drug resistant tuberculosis, Johnson & Johnson’s (NYSE: JNJ ) bedaquiline (Sirturo), an important breakthrough in the global fight against one of the world’s deadliest diseases.
Made by J&J’s Janssen Therapeutics division, based in Titusville, NJ, bedaquiline is meant for patients who have failed to respond to all other treatments.
It works by blocking an enzyme critical to the replication of M.tuberculosis bacteria, and the company said it is the first new drug in 40 years to attack TB via a new mechanism of action.