Comments on draft guidance invited until 31 January 2017
The European Medicines Agency (EMA) 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 31 January 2017.
TB is caused by a bacterium called Mycobacterium tuberculosis. In Europe, approximately 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.
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.
The guidance also clarifies the European Union’s regulatory requirements with regard to data that should be generated to support the approval of new medicines or combinations of medicines, and provides direction on the following topics:
- evaluation of the efficacy of individual new medicines and regimens in light of recently approved medicines;
- evaluation of new regimens including at least one new medicine;
- role of biomarkers to predict the effectiveness of the medicine(s) during clinical development.
Comments on the draft guideline should be sent to firstname.lastname@example.org using the form provided.
EMA will host a workshop in November 2016 to discuss stakeholders’ comments on the revised guidance. Comments will be taken into account in the finalisation of the guideline. The workshop will be broadcast live.