Janssen's Sirturo gets conditional EU approval for multi-resistant TB

US health care giant Johnson & Johnson’s (NYSE: JNJ) European subsidiary Janssen-Cilag has been granted conditional approval by the European Commission for Sirturo (bedaquiline), for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

The decision from the EC follows a positive opinion late last year from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines recommending the approval of bedaquiline (The Pharma Letter December 22, 2013).

“We are delighted that Sirturo has been approved for use in the European Union, as it represents a significant step forward in helping address a very serious global public health issue,” said Wim Parys, head of R&D, global public health at Janssen. “We will continue to work with partners and relevant authorities to ensure Sirturo is used correctly and appropriately, and we recognize the importance of educational efforts in informing physicians and patients about appropriate use," he added.