The European Medicines Agency (EMA) has commenced a public discussion on revised regulation on the development of new medicines to treat tuberculosis (TB). The regulation is an addition to EMA’s guideline on the assessment of medicines to treat bacterial infections.
TB is caused by a bacterium called Mycobacterium tuberculosis. In Europe, about 340,000 new TB cases and 33,000 deaths were reported in 2014, frequently from eastern and central European countries. While TB is slowly dilapidated worldwide, the trouble of the disease is still very high with just about 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 TB treatments cannot efficiently fight the disease because they are long, intricate, and usually show abridged effectiveness against MDR-TB, striking a heavy burden on patients, families and healthcare systems. New TB medicines and regimens that are simpler to administer, are of shorter duration, and can conquer drug resistance are without delay needed.
In modern years, there has been a shift towards rising completely new regimens to treat TB, rather than focusing on single medicines. The revised guidance takes into account this expansion.
The direction also illuminates the European Union’s regulatory chucks with regard to data that should be produced to hold up the endorsement of new medicines and gives direction on the following topics:
- assessment of the effectiveness of entity new medicines and regimens in light of newly standard medicines;
- assessment of new regimens including at least one new medicine;
- Functioning of biomarkers to calculate the effectiveness of the medicine during clinical development.
EMA will arrange a workshop in November 2016 to confer stakeholders’ comments on the revised regulation.
Stakeholders can send their comments to the Agency until 31 January 2017.
Dated: 01/08/2016