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A life-changing, drug-resistant tuberculosis treatment option from J&J could give new hope to patients for the first time in 40 years.

By Anonymous on Jan 2, 2013

Recently, Johnson & Johnson’s innovative tuberculosis (TB) tablet Sirturo (bedaquiline) received priority review as well as a fast-track and orphan-product designation from the FDA. The drug was approved using a limited amount of clinical data than required for traditional drug approvals. Sirturo will be used for patients with "multidrug resistant pulmonary tuberculosis (MDR-TB) when alternative therapies are unavailable.The drug’s Phase 2 studies which, demonstrated that 77.6% of patients in the relevant treatment group had a successful reaction to the drug after 24 weeks, were used in the approval process. This phase 2 study figure was higher than the original 57.6% in the placebo group.   

Even though treatment options for TB exist worldwide, it is still a prevalent health issue. Less than 100 US patients have MDR-TB although FDA approval will strengthen the acceptance rate in countries like India, Russia, South Africa and China where the disease is more widespread. A WHO report states that out of 8.7 million new TB cases worldwide, 400,000 were accountable for the MDR version of TB. Although the drug is not expected to be very profitable for J&J, it is hoped that it will help build relationships with patients, regulators and governments around the world.

J&J spokesperson Pamela Van Houten said: “The commercial opportunity is very limited. This is part of our commitment to advance innovative medicines that help address serious public-health issues.” J&J will start selling Situro in the second quarter of 2013. With this approval, the FDA will also give J&J a voucher that grants an accelerated review of another treatment.  

Although the approval of Sirturo should be praised, the FDA requires the new medication to contain a prominent warning label indicating that this treatment can cause fatal abnormal health rhythms. Around 11.4% of patients taking the drug the drug died during the clinical trials as compared with 2.5% during the placebos. But, it is still unclear whether Sirturo caused this increased death rate. Chief Executive of the Global Alliance of TB Drug Development Mel Spigelman said: “It looked more likely that this was just a bad coincidence. But you have to be careful, and the monitoring will have to be rigorous.” This organisation will be partnering with J&J to develop the use of Sirturo for common types of TB.          

J&J will begin the final-phase trial for this drug in the early quarter of 2013. Therefore, the real effects of this game changing drug remain to be seen.