Accessing Our Therapies through EAP
An Expanded Access Program (EAP) is the use of an investigational drug that is not approved by the appropriate health authorities (i.e. Health Canada and/or the U.S. Food and Drug Administration (FDA)) and is only for patients who are unable to participate in a clinical trial.
An EAP is a program intended to allow a patient to access an investigational drug for a serious or immediately life-threatening condition where no comparable or satisfactory alternative therapy exists, the potential benefit of the investigational drug justifies the potential risks, and those risks are reasonable in the context of the disease or condition being treated.
IMV Inc. will accept EAP inquiries from prescribing healthcare practitioners only. Patients with inquiries are encouraged to review resources such as clinicaltrials.gov and discuss options with their treating physician. Inquiries that fulfill the general criteria outlined above will be provided with an application and instructions for completion.
Upon receipt of a completed EAP application and required supporting documentation, IMV will evaluate that:
- There is substantial scientific evidence to support both the safety and potential efficacy of the investigational drug for the proposed use, with the proposed patient;
- The patient cannot access the investigational drug within one of the existing clinical trials
- There is an adequate supply of the investigational drug;
- The investigational drug can be safely and logistically administered outside of a clinical trial setting.
- Not all EAP requests will be granted. If a request is approved by IMV, please allow additional time for the appropriate health authority approval which will be the responsibility of the prescribing physician to obtain.
For more information on accessing our therapies through our EAP, please provide details by email at [email protected].