Bedaquiline for MDR-TB – EMA’s opinion (90 min.)

Janssen Therapeutics also applied for market approval of bedaquiline (brand name Sirturo®) in Europe. The EMA assessed their application which consisted of precisely the same data that were submitted to the FDA. Bedaquiline was also approved for the EU market. You may expect that FDA and EMA came to the same conclusions, is that the case?