Public Citizen urges FDA to reject accelerated approval for Janssen's bedaquiline
The US Food and Drug Administration should not approve the anti-tuberculosis drug bedaquiline from Janssen, a unit of health care giant Johnson & Johnson (NYSE: JNJ), because clinical trials showed the drug could be highly dangerous, said consumer advocacy group Public Citizen said in a letter to the agency last week.
An FDA advisory committee recently voted unanimously to support approval of the product, agreeing that the efficacy findings for its investigational drug bedaquiline (proposed trade name Sirturo) support the proposed indication for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults (The Pharma Letter November 29).
Phase II trials showed "alarmingly increased" risk of death
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