Sirturo approved for multi-drug resistant TB
A new drug Sirturo has received conditional approval for treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB).
The spread of multi-drug resistant TB is a growing global health problem, not just in the least developed nations, but also in developed countries, where the disease is staging a comeback.
MDR-TB is a particularly complicated form of TB, resisting at least two of the standard four-drug, anti-TB drugs. Inadequately treated patients are likely to increase selective pressure, allowing resistant bacteria to thrive and pose a risk of transmitting the disease to the general population. Without significant public health intervention, MDR-TB is projected to infect more than two million people between 2011 and 2015.
Janssen-Cilag's Sirturo (bedaquiline) can be used as part of a combination regimen in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
"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 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 recognise the importance of educational efforts in informing physicians and patients about appropriate use."
Sirturo was discovered by scientists at Janssen and has a unique mechanism of action that inhibits mycobacterial ATP (adenosine 5'triphosphate) synthase, an enzyme essential for the generation of energy in Mycobacterium tuberculosis. The conditional approval is supported by 24-week data from Phase 2 trials which included a trial that evaluated Sirturo versus placebo in patients with pulmonary MDR-TB in combination with a background regimen (TMC207-C208) and an open-label study (C209). The durability of effect was supported by 120-week data from the Phase 2 trial.
In Phase 2 studies, the Sirturo treatment group had a decreased time to culture conversion and improved culture conversion rates compared to the placebo group. The median time to culture conversion was 83 days for the Sirturo group, compared to 125 days for the placebo group at week 24. At week 120, treament with Sirturo continued to result in a significantly improved culture conversion rate versus placebo.
The proportion of patients defined as cured at 120 weeks was 57.6% in the Sirturo arm vs. 31.8% in the placebo arm
"MDR-TB is associated with a high mortality rate and poses a significant public-health threat, as individuals infected with drug-resistant strains are often unable to receive adequate treatment and can potentially spread their infection," said Professor Martin Grobusch, Head of the Centre for Tropical Medicine and Travel Medicine, University of Amsterdam. "Today's approval is a critical step forward in tackling this rapidly growing disease and speeding up patient access to much needed treatment."
The conditional approval includes a pledge by Janssen to support a Phase 3 study to further substantiate the benefit-risk for Sirturo and define its optimal use, with regards to the number and types of agents that are needed in combination, and its optimal treatment duration.
Sirturo has received accelerated approval in the US and has been registered in the Russian Federation by JSC Pharmstandard, the company Janssen signed a license agreement with in 2013 for Russia and the Commonwealth of Independent States. Regulatory filings have also been submitted in South Africa, China, India, Thailand, Vietnam, Colombia, and South Korea.
Janssen will conduct a Phase 3 study to further substantiate the benefit-risk of the drug and define its optimal use with regards to the number and types of agents that are needed in combination, and the optimal treatment duration.
Janssen Global Public Health is a separate division with the Janssen Pharmaceutical group and focuses on innovative strategies that improve access to medicines, foster collaborations, and support public health solutions to sustainably advance health care worldwide. Current focus includes multi-drug resistant tuberculosis; HIV; elephantiasis and river blindness; intestinal worms; and use of mobile technologies (mHealth) to improve health outcomes.
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