Imara Expanded Access Policy
Imara is dedicated to developing novel therapeutics for patients with sickle cell disease and other hemoglobinopathies. Sickle cell disease represents a critical unmet medical need globally in which it is considered as a rare disease in many parts of the world, including in the United States, and as an endemic condition in several African countries. Imara’s lead product candidate, IMR-687, is under development for the treatment of sickle cell disease. Currently, Imara does not have an expanded access program for IMR-687.
Expanded access may provide an avenue to use an investigational product, such as IMR-687, outside a clinical trial to diagnose, monitor, or treat a serious condition or disease in a patient. Imara has used guidelines from the US Food and Drug Administration (US FDA) and other regulatory agencies to develop the following criteria for when expanded access may be made available on a case-by-case basis for individual patients:
- Ongoing or planned clinical studies are not available to the patient, including lack of access due to geographical location of potential clinical trial sites,
- Significant evidence exists that supports both the safety and the efficacy of the investigational drug for the indication,
- The potential benefits to the particular patient seeking access to the investigational drug outweigh the potential risks to the patient,
- An adequate supply of the investigational drug exists,
- All necessary regulatory/institutional approvals have been obtained to allow drug administration, and
- The request for expanded access has been made by a qualified health care provider with expertise appropriate for the administration of the drug and for monitoring and managing the patient.
Imara supports expanded access programs and the need for a suitable policy, and it intends to provide patients with sickle cell disease access to IMR-687 at a suitable time and in the correct method when used outside a clinical trial. At this time, Imara believes that the most appropriate way to use our investigational lead product candidate, IMR-687, is by participation in one of our clinical trials (https://clinicaltrials.gov/). If you have additional questions, please speak with your health care provider or contact firstname.lastname@example.org. Imara will typically respond to requests sent to this email address within five business days.
Imara may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.