ARTICLE | Company News

Conditional EU approval for J&J's bedaquiline

March 7, 2014 2:20 AM UTC

The European Commission granted conditional approval to an MAA from Johnson & Johnson (NYSE:JNJ) for Sirturo bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. The approval covers use of bedaquiline as part of a combination therapy when alternative treatments cannot be used due to resistance or intolerance. Bedaquiline also has accelerated approval from FDA for pulmonary MDR-TB as part of a combination therapy when other alternatives are not available (see BioCentury Extra, Jan. 2, 2013). ...