Early access programs in Europe: a regulatory tool with pre-marketing impact

Early Access Programs are country-specific regulatory tools that allow a drug to be available on the market before its official launch, providing that it fulfils specific criteria. Despite potential significant advantages of these programs, many pharma/biotech companies remain unaware of the possibilities available in Europe. In addition, even amongst the informed minority, many assume - wrongly - that an EAP will be too risky, too complicated or too costly to consider. Alain Gilbert, Vanessa Caignault and Murielle Foist of Bionest Partners explain why European EAPs are worth considering by pharma/biotech companies.

They cite the cases of Actelion's Tracleer (bosentan) for pulmonary arterial hypertension (also granted orphan drug status) and Sanofi-Aventis' Eloxatine (oxaliplatin), for use in metastatic colorectal cancer, which were available in Europe via EAPs prior to their official launches.

Neither of these drugs, now firmly established as cornerstone therapies in their respective target conditions, were initially predicted to be the blockbusters they are today. The Tracleer EAP raised awareness of the need to diagnose and treat the disease early among a growing number of non-PAH experts. Eloxatine's success was based on strong market penetration achieved by its EAP, which resulted in very profitable returns once on the market. These successful EAPs demonstrate that such programs can be invaluable components of pre-launch activity.