Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

When seeking expanded access to an investigational medical product, it is critical that the patient and his/her licensed physician consider all possible risks. Investigational medical products have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

Whenever possible, an investigational medical product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational medical product.

Factors consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines should be taken into account when considering expanded access. These include:

• The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
• Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
• Whether granting expanded access would potentially compromise the scientific validity of broader development many more patients

At this time, we believe that participation in one of our clinical trials is the appropriate way to access our investigational therapies.

If you have additional questions, please speak with your physician or contact expandedaccess@polarispharma.com. We anticipate acknowledging receipt of requests sent to this email within five business days.

Polaris 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.

You can view a full list of our clinical trials, here.