Occasionally, patients with serious or life-threatening diseases or conditions seek access to investigational medicines outside of a clinical study setting. The associated provision for requesting access to an investigational medicine is called ‘Expanded Access’ but is also known by other terms such as ‘Compassionate Use’, ‘Early Access’, and ‘Emergency Use’. Patients who seek access to investigational medicines outside of an established clinical study and prior to health authority marketing authorization may wish to do so because standard treatments have failed, they cannot tolerate already approved medicines, because they are unable to participate in a clinical study or because there are no comparable or satisfactory therapy options available outside of clinical trials.
Our policy below sets forth the general guidelines that Epizyme will apply to its Expanded Access Program to ensure that requests for access to our investigational medicines are considered and processed in accordance with applicable legal and regulatory requirements, as well as in alignment with principles consistent with the Company’s policies and procedures. This Policy is applicable globally and across all therapeutic areas.
Find our full expanded access policy here.
Further information about Epizyme’s clinical trials is available at ClinicalTrials.gov.