USING EXPANDED ACCESS AS AN ALTERNATIVE TO AN OPEN LABEL EXTENSION (OLEX) STUDY
Condition
Debilitating neurological disorder
Drug Type
Investigational
Trial Phase
Completed Phase 3
About Sponsor
The Sponsor is a global pharmaceutical company focused on developing next-generation drugs to treat a number of CNS disorders. With headquarters in the US, the company has a diverse pipeline of products which it is committed to bringing to the US and global markets.
Challenge
The Sponsor needed to end a long standing OLEX study, that was set up after its phase 3 trials had ended. However, the company wanted to continue providing drug access to patients, to fill the lag period before the product becomes commercially available.
This would involve closing out the OLEX study and transferring 861 patients, located across 19 different countries, into a new program.
WEP Solution
The Sponsor partnered with WEP Clinical to provide patients drug access through an EAP. WEP worked with the Sponsor and their existing CROs to close down the OLEX. At the same time, the EAP was set-up to allow a smooth and seamless transition of patients. All patients had been transferred across in 3 months. The EAP has resulted in a significant cost saving to the Sponsor, while allowing the sponsor to meet their commitment to continue patient treatment.
Outcomes:
The program is expected to run for 3 years
Over 2000 units of drug have been shipped
543 patients have been approved into the EAP
Patients in 13 countries* across 4 continents
*Argentina, Australia, Chile, Czech Republic, France, Germany, Hungary, Israel, Poland, Serbia, South Korea, Spain, Sweden, and Ukraine