N.J. pharma company wins FDA approval for first of its kind TB drug
January 1, 2013By Zack Seward
Tuberculois is a bacterial infection that attacks the lungs. The disease is contagious, can be fatal and has slowly outsmarted some of the drugs used to treat it.
That's where Janssen Therapeutics of Titusville, N.J. comes in.
The firm — one of the pharmaceutical companies of Johnson & Johnson — has just won FDA accelerated approval for a new tuberculosis drug. Janssen announced Monday that SIRTURO will be commercially available in the U.S. by the second quarter of 2013.
The new drug will address a small problem domestically, admits Janssen spokesperson Pamela Van Houten. But it could be a key weapon in the fight against a growing menace abroad.
"This compound was discovered by Janssen scientists in our laboratories, and we really felt that it was just too important to not develop," Van Houten said.
SIRTURO is the first ever medicine designed specifically for multi-drug resistant TB.
In 2011 there were only 98 reported cases in the U.S. "However, globally there were over 600,000 cases," said Van Houten. "This is a disease that is on the rise and is very, very important to treat when it occurs."
Multi-drug resistant TB is most prevalent in parts of Central Asia, Eastern Europe and Africa.
Janssen will continue testing the drug while it seeks approval for SIRTURO in those markets. Van Houten says U.S. approval is key, however, because global regulators often look to the FDA.