EBE/Europabio fight demands for early orphan drug data release
Organisations argue against EC plans to require discussion of pre-clinical and preliminary clinical data in orphan drug designation applications
The European Biopharmaceutical Enterprises (EBE) and EuropaBio industry bio-pharma industry organisations have argued against European Commission plans to require discussion of pre-clinical and preliminary clinical data in orphan drug designation applications.
In consultation over planned changes to the European Union’s (EU) guidance on orphan medicine regulations, the EBE and EuropaBio claim this could delay orphan drug applications so that companies lose financial incentives available for initial application steps. 'Sponsors may have to wait with their OD application until they obtained sufficient data…,' they warned.
They advise allowing pharma companies to instead use data from other products developed for the same condition 'with adequate extrapolation and appropriate scientific rationale…' It said: 'In many cases, at the time of designation, little or no clinical experience is available…'
The organisations also called for a common complete application covering orphan drug designations by both the European Medicines Agency (EMA) and the USA’s Food & Drug Administration (FDA).