Optimizing development of combination therapies: the regulatory perspective

Optimizing development of combination therapies: the regulatory perspective

Following on from MMV’s recent meeting to discuss selection of the right partner drugs for new combination therapies, the discussion was taken a step further on 5 October 2010 at a meeting to decipher the optimal development strategies to bring such new combination therapies to fruition.

Scientific evidence in the anti-infective field holds that combination therapy is vital to prevent  the development of drug resistance and assure adequate cure. But how do we get from a single antimalarial agent, with demonstrated efficacy, to a combination therapy ready to treat patients?

Currently available combination therapies, as well as those undergoing registration, comprise single agents that have been in use for a number of years. Long experience with these individual medicines provides a strong basis to guide the development plan for their use in combination therapies. Today, however, the development of innovative antimalarial medicines has entered a new era, with new single agents, such as OZ439, progressing through the MMV pipeline. Once the partner drug has been selected for these new agents, the next challenge is to design a development plan for the combination that is both cost- and time-efficient and acceptable from a stringent regulatory perspective.

These challenges were debated at the meeting by drug development experts from the fields of HIV, TB and malaria, as well as representatives from the WHO Global Malaria Programme, European Medicines Agency, the UK Medicines and Healthcare Products Regulatory Agency and the US Food and Drug Agency. The meeting provided a useful forum to discuss regulatory issues governing the development of new combination therapies and was a great opportunity to share experiences.

See the meeting agenda.