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EAP Case Studies2019-07-30T09:50:25+01:00

Using expanded access as an alternative to open-label extension

Challenge

A pharmaceutical company developing a disease modifying therapy for a neurodegenerative disease wanted to continue the supply of the investigational product to patients who had completed its Phase 3 clinical trials. These patients were initially receiving access to the medication via an open-label extension. However, when the open-label phase was discontinued, some patients found they were unable to enroll onto alternative clinical trials and were left with limited treatment options.

Using expanded access to treat patients outside of clinical trials

Challenge

A pharmaceutical company developing a new treatment for a rare neurodegenerative disease had to set very strict eligibility criteria for its clinical trial. As a result, there were patients who wanted to access the company’s investigational drug but found they could not enroll in the study. Because there are no approved treatments for this condition, these desperate patients were contacting the company and requesting non-clinical trial use of the product.

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