by E4H | Jan 9, 2023 | Insights
Expanded access programs (EAPs) can be instrumental in both ensuring patient access to treatment, and as a key step on the path to commercialization. How Expanded Access Can Complement Rare Disease Drug Development The National Institute of Health estimates that there...
by E4H | Jan 9, 2023 | News
FINTEPLA is approved in the U.S. and European Union as an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. The new program supports physician access to FINTEPLA in other parts of the world, where local...
by E4H | Jan 9, 2023 | Insights
When considering running an expanded access program (EAP), drug manufacturers typically find themselves at a crossroad, weighing the benefits of delivery against the obstacles that might be in the way. But often, the value is much greater than the challenge,...
by E4H | Jan 9, 2023 | Insights
Increasingly, the value, uses and benefits of Real-World Data (RWD) collection in EAPs are being realized by pharmaceutical and biopharmaceutical manufacturers all around the world. Most commonly, RWD is used to support reimbursement or Health Technology Assessment...
by E4H | Jan 9, 2023 | Insights
Anyone who has run an expanded access program (EAP) will know of the challenges that exist with addressing and satisfying the needs of each group or stakeholder involved in the process. And this is true regardless of the therapeutic area or drug type. Planning an EAP...
