Expanded Access Program

In some cases, patients with a serious or life-threatening disease or condition may not be able to access some of our investigational medicines through a clinical trial and may not have other treatment options available. In very specific circumstances, these patients may be able to receive investigational medicines outside a controlled clinical trial through our Expanded Access Program.

Expanded Access, sometimes called “compassionate use”, 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 for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The U.S. FDA advises that Expanded Access may be appropriate when all the following apply:

· Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.

· There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

· Patient enrollment in a clinical trial is not possible.

· Potential patient benefit justifies the potential risks of treatment.

· Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

For more information about expanded access in the U.S., please visit the FDA website at 


To learn more about our clinical trials, including your potential eligibility to participate, consult with your doctor or visit our Clinical Trials page. Your doctor can review with you, qualifying factors for participation, details of the investigational drug, and the clinical trial process.

If you have additional questions, please speak with your physician or contact us.