Sirturo bedaquiline regulatory update

EMA's CHMP issued a positive opinion recommending conditional approval of an MAA from Johnson & Johnson's Janssen-Cilag International N.V. unit for Sirturo bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. The recommendation covers use of bedaquiline as part of a combination therapy when alternative treatments cannot be used due to resistance or intolerance. CHMP recommended conditional approval because the data supplied by J&J show bedaquiline's benefits outweigh its risks but "are not yet comprehensive." Bedaquiline has Orphan Drug designation in the EU. ...