LONDON, Dec 23 (APM) - The European Medicines Agency (EMA) has so far selected six medicines to go forward in its adaptive licensing pilot project, which provides a “safe haven” allowing non-binding confidential discussions to help shape development.
In a late Monday statement the EMA said it had received 34 requests from companies to include their medicines in the pilot project, now called adaptive pathways, up to the beginning of December.
Of these, six concerned an advanced therapy, 12 were for orphan drugs and 11 came from small or medium-sized companies.
The medicines covered a “broad range” of therapeutic areas, the EMA said in the statement giving an update about the project, and 14 relate to cancer indications.
The EMA will not publish details of which medicines have been selected as confidential discussions are ongoing.
Launched in March, the adaptive licensing pilot project is a response to the need to find more drugs for rare or difficult to treat diseases.
Patient pressure led to the EMA creating the system (APMMA 40468) as well as the introduction of similar initiatives in the U.S.
The approach foresees an initial approval in a well-defined, high medical need subgroup and subsequent widening of the indication to a larger patient population, or a pre-planned early, perhaps conditional approval where uncertainty is reduced through post-approval data collection.
In the first phase of the project, the EMA will select drugs with a well-designed plan for an adaptive pathways approach, including issues such as engaging with HTA bodies, real world data and a plan for staggered extension of indications.
This phase will close at the end of February. The agency will focus on phase two of the project, where those selected will meet face-to-face with regulators.
After February 28, EMA will still consider new applications for the second stage face-to-face meetings if the HTA and real world data collection aspects are well-developed. Applicants can contact EMA (adaptivepathways@ema.europa.eu) for advice on the content and suitability of their request to be considered.
A full review of the outcome and impact of the adaptive pathways pilot project will be conducted once at least six medicines selected for the pilot have completed a procedure of parallel scientific advice with HTA bodies.
rs/hlc
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