FDA panel backs J&J tuberculosis drug
RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.
J&J subsidiary Janssen Research & Development said the FDA's 18-member Anti-Infective Drugs Advisory Committee voted unanimously that the results of clinical trials of the drug bedaquiline supported its approval for treating pulmonary multi-drug resistant tuberculosis as part of drug-combination therapy. The committee voted 11-7 that the drug was sufficiently safe for this use as well. The FDA isn't required to follow advisory committee votes, but usually does.
"We are pleased with the committee's recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB," Janssen global head of development for infectious diseases and vaccines Wim Parys said. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."
Janssen said the the FDA assigned a priority review designation to the regulatory application for the drug, which the company filed in June, seeking accelerated approval.