Regulatory News

EMA Revises Guidance on Developing New TB Medicines

The European Medicines Agency (EMA) on Monday launched a public consultation on revised guidance for companies developing new drugs to treat tuberculosis (TB).

Comments on the guidance, which is an addendum to EMA’s guideline on the evaluation of medicines to treat bacterial infections, will be accepted until 31 January 2017.

Background

TB, caused by a bacterium called Mycobacterium tuberculosis, affects 340,000 new people annually in the EU, and in 2014, 33,000 deaths were reported, mostly from eastern and central European countries.

In addition, multidrug-resistant tuberculosis (MDR-TB) poses a serious public health challenge and often affects migrant workers, refugees, displaced persons, prisoners or drug users.

EMA notes that existing TB treatments cannot effectively combat the disease because they are lengthy, complex, and generally show reduced efficacy against MDR-TB, meaning new TB medicines and regimens that are simpler to administer, of shorter duration and can overcome drug resistance are needed.

New Guidance

The revised guidance takes into account a developing trend in recent years, in which there has been a shift toward developing entirely new regimens to treat TB, rather than focusing on single medicines.

The update also clarifies the EU’s regulatory requirements for data that should be generated to support the approval of new medicines or combinations of medicines, and provides direction on evaluating the efficacy of individual new medicines and regimens in light of recently approved medicines; evaluating new regimens with at least one new medicine; and the role of biomarkers to predict the effectiveness of a new drug during clinical development.

“Since the adoption of the prior guidance advances have been made in the application of pharmacokinetic-pharmacodynamic (PK-PD) analyses to identify potentially efficacious doses and regimens for further clinical evaluation,” EMA says. “In particular, the use of in-vitro pharmacodynamic models early on in the development programme, with further refinement when human PK data become available, may play an important role in minimising the extent of dose- and/or regimen-finding clinical trials.”

Sections on microbiological data and patient selection also feature prominently in the new draft.

Comments on the revised guidance should be sent to idwpsecretariat@ema.europa.eu and EMA will host a workshop in November 2016 to discuss the comments.

EMA guidance