Janssen receives CHMP backing for new tuberculosis therapy

Janssen has announced that its tuberculosis drug Sirturo has been recommended for EU approval as part of a new treatment approach.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional marketing authorisation of Sirturo for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adult patients for whom an effective treatment regimen cannot otherwise be composed, for reasons of resistance or tolerability.

Data from a 24-week phase II clinical development programme has underlined the potential safety and efficacy benefits of the new regime, which has been designed to combat a dangerous form of tuberculosis that kills around 150,000 people annually.

The CHMP's positive opinion will now be considered by the European Commission, which will take a final decision on its approval soon.

In November 2013, Janssen was granted European regulatory approval for its new type 2 diabetes drug Invokana, based on positive data from phase III trials.