FDA panel backs J&J tuberculosis drug
RARITAN, N.J. (AP) — Johnson & Johnson said that a panel of federal health experts ruled that its experimental treatment for multidrug-resistant tuberculosis appears to be safe and effective.
J&J's Janssen Research & Development has asked the Food and Drug Administration to approve bedaquiline, or TMC207, as part of combination therapy for adults with multidrug-resistant tuberculosis lung infections.
On Wednesday a panel of outside experts voted unanimously that the drug is effective in treating patients with the disease. The same panel voted 11-7 that the drug was safe for the indication. Some panel members raised concerns about abnormal liver enzymes in patients treated with the drug.
The FDA is not required to follow the panel's advice, though it often does.
The agency has agreed to evaluate the drug under its priority review system, which aims to decide whether to approve an application within six months, rather than the standard 10 months. Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.
About 1.4 million people worldwide die from tuberculosis each year, roughly 10 percent of them from forms resistant to at least two of the standard drugs for the deadly bacterial disease.
J&J applied for approval to market the drug in the European Union on Aug. 31.