Navigating the transition from open label extensions to early access programs

Discover the strategic pathway to European market access for rare disease therapies.

The European orphan drug market presents a significant opportunity for biotech firms, with forecasts predicting substantial growth in the coming years. Early access programs (EAPs) have emerged as a critical strategy for successfully launching rare disease therapies in this complex and diverse market.

In this whitepaper you will learn:

• The transition from open label extensions (OLEs) to early access programs (EAPs)
• Key benefits of EAPs, including faster market entry and valuable real-world data collection
• Navigating complex European regulatory landscapes
• Strategies for successful EAP implementation
• And more