EMA consults on revised guidance for tuberculosis drugs development


European regulator invites comments until January 2017

The European Medicines Agency (EMA) has opened a public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB).

The guidance is an addendum to the European regulator's advice 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 the Mycobacterium tuberculosis bacterium. In Europe, approximately 340,000 new TB cases and 33,000 deaths were reported in 2014, mostly in eastern and central European countries.

While TB is slowly declining worldwide, there continue to be approximately 1.5 million deaths per year.

Multidrug-resistant tuberculosis (MDR-TB) also continues to pose a serious risk to public health. It often affects people from the most vulnerable communities, including migrant workers, refugees, displaced persons, prisoners or drug users.

Multidrug-resistant tuberculosis (MDR-TB) also continues to pose a serious risk to public health

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, the Agency says.

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 this into account.

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 should be sent to idwpsecretariat@ema.europa.eu using the form provided.

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EMA will host a workshop in November to discuss the comments, which will be taken into account in the finalisation of the guideline.