Biogen

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

Early Access | Biogen Opens in new window

“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.”

EAP Related Articles from Sponsor

Score contribution: 80 — 6 supporting sources.

Score 806 references

Featured Reference

Access and Health Equity | BiogenOpens in new window

Our Global Access Mechanisms are designed to help bridge gaps, and have become even more important as our pipeline continues to advance more innovative treatments for severe and life-threatening conditions where alternative treatments do not yet exist. Through ongoing collaboration with regulators, clinical researchers, ethicists, physicians and Patient Advocacy Groups (PAGs), we regularly evaluate and refine our approach so our access programs align with regulatory standards while reflecting our patient-focused values.

Clinical Trials | BiogenSource

Patients may potentially gain access to an investigational drug or a drug that is not yet approved in their country through our expanded access programs.

Medical ProfessionalsSource

Patients may potentially gain access to an investigational therapy or a therapy that is not yet approved in their country through our expanded access programs.

2024 Corporate Responsibility Report | Biogen Source

# 40+ Countries where Biogen Early Access Programs are available

Helping a baby with SMA in Kosovo | BiogenSource

Note: People must meet specific criteria to receive access to Biogen’s therapies through compassionate use based on humanitarian grounds or through our humanitarian aid program. Biogen’s increasing global operational footprint facilitates reaching more patients and helps us better understand local needs.

Company | BiogenSource

# 40 countries served by our Expanded Access Program

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 3 supporting sources.

Score 403 references

Featured Reference

Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral SclerosisOpens in new window

Conditions: Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Expanded Access Program (EAP) for Nusinersen in Participants With Infantile-onset (Consistent With Type 1) Spinal Muscular Atrophy (SMA)Source

Conditions: Infantile-onset Spinal Muscular Atrophy

Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401Source

Conditions: Melanoma

Expanded Access Intelligence

Official Statements

Past EAPs on ClinicalTrials.gov

Reagan-Udall Foundation Insights

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