Fighting Tuberculosis with Bedaquiline

Excelsior Correspondent
7TB claimed more lives in history than any other infectious disease – and it still does: about 2 million people die from it, every year. One every 17 seconds, today, now.In 1882, Dr. Robert Koch identified Mycobacterium tuberculosis as the causative agent of tuberculosis (TB), and since his discovery, the global TB epidemic seems unabated; this year it is anticipated that there will be about 9.8 million new cases, more than in any year in history.
This situation highlights the relative shortcomings of the current treatment strategies for TB and the limited effectiveness of public health systems, particularly in resource-poor countries where the main TB burden lies. In recent years, the TB epidemic has been fuelled by co-infections with Human Immunodeficiency Virus (HIV), emergence of multi-drug-resistant (MDR) strains, and dwindling treatment options which are many years old. The last drug with a new mechanism of action approved for TB was rifampicin (discovered in 1963) and in the last 4 to 5 decades no new regulatory approvals occurred.
TB is more prevalent than ever and the emergence of multi-drug-resistant (MDR) strains increases the importance of new drug discovery. The world’s two most populous countries, India and China, account for more than 50% of the globe’s MDR-TB cases and as such these countries are encountering a high and increasing disease burden. The emergence of XDR strains of M. tuberculosis is challenging TB treatmentprograms in several other countries and even raises the possibility of a return to the pre-antibiotic TB era.  Currently, MDR-TB is treated by a combination of eight to ten drug, therapies lasting up to 18-24 months, and only four of these drugs were actually developed with a purpose to treat TB.  Such suboptimal therapy leads to almost 30% of MDR-TB patients experiencing treatment failure.
On the eve of new year, it has been a great pleasure to inform that FDA has granted accelerated approval to bedaquiline (or SIRTURO) for treatment of MDR- tuberculosis as part of combination therapy in adults (please see the link: http://www.medscape.com/viewarticle/776901). It is great news for drug resistant TB patients who will have more options to treat and cure the disease.
Janssen got approval for the new TB drug Sirturo, on basis of more than 10 years of research. Recent clinical data from have revealed the efficacy of a novel anti-TB drug, bedaquiline (BDQ, marketed as Sirturo®), in treatment of MDR-TB.  SIRTURO was granted accelerated approval by the US Food & Drug Administration for the treatment of pulmonary MDR-TB as part of combination therapy in adults. This marks the first regulatory approval of an anti-TB drug since the introduction of rifampin in 1971. BDQ is a first-in-class ATP synthase inhibitor, displaying high selectivity for mycobacterial ATP synthase.New medicines are important in general – they address medical needs. And a medical need is not an abstract thing – this is about patients’ lives.  New medicines for TB are extremely important.

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