The European Medicines Agency (EMA) publishes today a report giving an update on the status ofthe adaptive pathways pilot project.

EMA has received 34 requests from companies to include their medicines in the adaptive pathways pilot project up to the beginning of December 2014. A total of six requests concerned an advanced-therapy medicinal product (ATMP), 12 requests were for orphan medicines, and 11 came from small- or medium-sized companies (SMEs). The medicines covered a broad range of therapeutic areas; 14 requests relate to cancer indications.

Following review and discussion with companies, six medicines have so far been selected to go forward into more in-depth discussions with the company with the participation of all stakeholders, including health-technology-assessment (HTA) bodies and patients’ representatives.

The first of these in-depth discussions, on the quality aspects of an ATMP, took place in December 2014, with others already planned during 2015.

The adaptive pathways approach (formerly known as adaptive licensing), is part of the Agency’s efforts to improve timely access for patients to new medicines. The concept of adaptive pathways foresees either an initial approval in a well-defined, high medical need subgroup, and subsequent widening of the indication to a larger patient population, or an early (perhaps conditional) approval which is prospectively planned, and where uncertainty is reduced through post-approval data collection.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/12/news_detail_002244.jsp&mid=WC0b01ac058004d5c1