EMA consults on development of medicines to treat tuberculosis

The European Medicines Agency has launched a public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB). The guidance is an addendum to EMA’s guideline on the evaluation of medicines to treat bacterial infections.

Stakeholders can send their comments to the Agency until January 31, 2017.

TB is caused by a bacterium called Mycobacterium tuberculosis. In Europe, around 340,000 new TB cases and 33,000 deaths were reported in 2014, mostly from eastern and central European countries. While TB is slowly declining worldwide, the burden of the disease is still very high with approximately 1.5 million deaths per year. Moreover, multidrug-resistant tuberculosis (MDR-TB) still poses a serious public health challenge. It often affects people from the most vulnerable communities, including migrant workers, refugees, displaced persons, prisoners or drug users.