USING EXPANDED ACCESS TO PROVIDE CONTINUATION OF TREATMENT POST CLINICAL TRIALS
Condition
Rare neurodegenerative disease
Drug Type
Investigational
Trial Phase
Completed Phase 3
About Sponsor
The Sponsor is a pharmaceutical company focused on the discovery, development and eventual commercialization of innovative, new medicines for neurodegenerative diseases. The Sponsor has its headquarters in Asia and research and development facilities across Europe.
Challenge
The Sponsor wanted to continue supplying its investigational product to patients who had completed its Phase 3 clinical trial. A traditional OLEX study was an option. However, the company did not require any formal post-trail data collection.
As such, it wanted to find a cost- and time-effective alternative so that patients were not left without treatment, while waiting for product approval and commercialization.
WEP Solution
The Sponsor partnered with WEP Clinical to set-up an EAP. The EAP was set up in around 2 months and has taken less time and fewer resources to manage than the OLEX study. Providing access through an EAP has also allowed the Sponsor to consider enrolling patients who had previously been excluded from the clinical trials. If these patients meet the EAP access criteria, they too can receive treatment prior to product approval and commercialization.
Outcomes:
The program has been running for over 4 years
3000 units of drug have been shipped
101 individual patients have been treated
Patients in 5 countries across 3 continents*
*Countries in scope: Belgium, Germany, Singapore, United Kingdom, United States