Early Access

Early access is a potential pathway for patients diagnosed with a serious and/or life-threatening disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. In these instances, a patient’s treating physician can request an investigational drug prior to regulatory approval, where allowed by local laws.

Biogen considers granting early access to investigational drugs when all the following criteria are met:

• A patient is diagnosed with a serious and/or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available to treat the disease or condition.
• The patient is not eligible to participate in a clinical trial.
• Sufficient data exists where the potential benefits of the treatment outweigh the potential risks for the disease to be treated.
• There is adequate supply of the investigational drug, and providing the investigational drug will not interfere with ongoing clinical trials or the overall development program.
• Investigational access provided in this setting is allowed per local laws and regulations.

Biogen is equally committed to enacting early access to investigational drugs in development for qualifying patients and communicating with the patient community, healthcare providers (HCPs), and healthcare systems on the timing of such programs.

The following principles guide decisions to provide access to our programs:

• Access for appropriate patient(s) to address high unmet medical need in a safe, ethical, and just manner in compliance with applicable laws and regulations.
• Access while ensuring the integrity of clinical trials and the development of medicines.
• Access that does not jeopardize the pathway to broad, long-term access and approvals through local health systems.
• Access that minimizes burden on healthcare systems, HCPs, patients, and families.