Janssen applies for EU approval of new tuberculosis therapy

Pharmaceutical Company Product News

Janssen has applied for European regulatory approval for its investigational compound bedaquiline to be used as part of a combination therapy for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults.

The company has submitted a marketing authorisation application to the European Medicines Agency for conditional approval of the oral therapy in this specification, following submission of a similar application to US regulators in June 2012.

Data from phase II trials has shown that bedaquiline can offer improved safety and efficacy compared to placebo, killing the bacterium that causes tuberculosis by targeting an enzyme that plays a key role in generating its energy.

If approved, it would become one of the first drugs with a new mechanism of action for tuberculosis to become available in more than 40 years.

Dr Wim Parys, head of the infectious diseases therapeutic area at Janssen, said: "This filing underscores our commitment to discover and develop novel medicines and solutions for serious unmet medical needs, and we hope this new treatment will become an important option for patients with MDR-TB."

This comes after the firm also recently announced that it has acquired rights to an innovative new anti-cancer compound called daratumumab from Genmab.

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