The event will be broadcast on 25 November 2016
The European Medicines Agency (EMA) is organising a workshop on the development of new medicines to treat tuberculosis (TB). The event will take place at EMA’s premises in London on 25 November 2016, from 9:00 to 16:00.
The workshop is part of the consultation process on the revision of EMA’s guidance for the development of new treatments for tuberculosis, an addendum to EMA’sguideline on the evaluation of medicines to treat bacterial infections. During the workshop, representatives from patient and healthcare professional organisations, academia, regulatory bodies and the pharmaceutical industry will discuss the updated draft requirements as part of the public consultation. The presentations and discussions of the event will be taken into account in the finalisation of theguideline.
TB is caused by a bacterium called Mycobacterium tuberculosis. In the World Health Organisation’s (WHO) European region, approximately 340,000 people were newly diagnosed with TB and 33,000 died from the disease in 2014, mostly in Eastern and Central European countries. While TB is globally slowly declining, the burden of the disease is still very high with approximately 1.5 million deaths per year worldwide. Moreover, multidrug-resistant tuberculosis still poses a serious public health challenge. It often affects people from the most vulnerable communities, including migrant workers, refugees, prisoners or drug users.
Today’s existing treatments for multidrug drug-resistant TB are not always very effective, imposing a heavy burden on patients, who often have only very limited healthcare systems to support them. New TB medicines and regimens (a combination of medicines) that are simpler to administer, are of shorter duration, and can overcome drug resistance are urgently needed.
In recent years, there has been a trend towards developing entirely new regimens to treat TB, rather than focusing on single medicines, an aspect that is taken into account in the revised guidance.
The workshop will be broadcast live on the EMA website on the event page.