J&J’s TB drug appears to be ‘safe’, says FDA
The US FDA has said that Johnson &, Johnson’s tuberculosis drug, bedaquiline, appears to be “safe and well-tolerated”.
The FDA released a review of the product in advance of the FDA’s anti-infective drugs advisory committee meeting made up of non-FDA medical experts on Wednesday 28th November. The FDA’s advisory panel will vote on whether the data submitted by the pharma company provides “substantial evidence” of the safety and effectiveness of bedaquiline as a tuberculosis treatment when used with other drugs.
J&,J is seeking accelerated approval of bedaquiline, which affects the proton pump for ATP synthase, for the treatment of drug-resistant tuberculosis.
The World Health Organisation was notified to just fewer than 60,000 cases of multi-drug resistant tuberculosis in 2011, mostly by European countries and South Africa.
FDA: Proposed J&,J Tuberculosis Drug Appears Safe (Automated Trader)
FDA Says J&,J’s TB Drug Appears Safe (Wall Street Journal)
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