Access to investigational therapies
- Types of access
- How to request access
At Biogen, our goal is to improve the lives of patients by researching and developing new and innovative therapies. Before these therapies are commercially available to patients, they must go through clinical trials and be approved by a regulatory authority — such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe — to treat a specific disease. Approval by regulatory authorities around the world is the fastest way to help the largest number of people with a specific disease. For most patients, the only way to access these “investigational therapies” is to participate in a clinical trial. However, patients with serious or life-threatening diseases may not be eligible or able to participate in clinical trials – and their physicians may determine that they have no other appropriate treatment options. In these situations – and when other essential criteria are met – patients may have access to investigational therapies through expanded use, which includes expanded access programs (EAPs) and single patient access (including emergency use).
The number of people who want access to a particular investigational therapy may be greater than the number of people who can receive it. At Biogen, we work with stakeholders, including patient advocacy organizations, ethicists, regulators, and physicians to determine how best to provide access to investigational therapies in an ethical manner consistent with our commitment to all patients. It is important to us that patients and caregivers can easily understand the methods by which we provide access. Learn more about access to and eligibility requirements for investigational therapies in this section.