EMA Launches Public Consultation on Guidance for New Tuberculosis Treatments

On August 1, 2016, EMA announced that it has launched a public consultation on the 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 comments to the Agency until January 31, 2017.

In 2014 Europe saw approximately 340,000 new cases of TB resulting in 33,000 deaths, EMA reports. 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, and drug users.

According to EMA, today’s existing TB treatments cannot effectively combat the disease because they are lengthy, complex, and generally show reduced efficacy against MDR-TB, imposing a heavy burden on patients, families, and healthcare systems. 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 shift towards developing entirely new regimens to treat TB, rather than focusing on single medicines. The revised guidance takes into account this development.