At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
We believe that no other disease area holds as much need or as much promise for medical breakthroughs as neuroscience. Our focus on neuroscience, our deep scientific expertise and our courage to take risks make us leaders in the research and development of medicines to transform neuroscience to benefit society.
We aspire to transform patients’ lives and Biogen by making personalized & digital medicine in neuroscience a reality. Powered by data science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. We believe that now, more than ever, biology and technology should go hand-in-hand to better meet patient needs, while enabling a shift towards more prevention-focused, affordable, and equitable care.
We came to Biogen to solve the unsolvable. We stay to create new possibilities and grow together. We work fearlessly and go beyond because we care deeply about making a difference and changing lives. All legitimate correspondence from a Biogen employee will come from “@biogen.com” or “@smartrecruiters.com” email accounts.
Our mission is to advance science in the development and approval of medications to benefit the greatest number of patients in a timely manner. Our ability to successfully complete the regulatory pathway and achieve the goal of broad therapeutic access for patients is essential to this mission.
Clinical trials are the main way for patients to access investigational therapies.
Biogen’s clinical trials are conducted to test the safety and effectiveness of investigational therapies so that regulatory authorities – such as the FDA in the United States and the EMA in Europe – can decide whether or not these therapies can be approved as a treatment for a disease. Biogen strives to design and run clinical trials that will provide these regulatory agencies with the data they need to determine if an investigational therapy is beneficial to people.
To participate in a clinical trial, a patient must meet the inclusion/exclusion (eligibility) criteria. These criteria are important because they help researchers identify people who can participate. The criteria also help researchers identify a group of people with similar characteristics of a disease, making it easier and quicker for the researchers to evaluate the investigational therapy – potentially leading to faster review and approval. Read more about clinical trials here.
Sometimes, patients with serious and/or life-threatening diseases or conditions who do not qualify for a clinical trial may seek medical products that are not yet approved or available in their country.
Biogen is equally committed to enacting early access for products in development for qualifying patients and communicating to the patient community, healthcare providers (HCPs), and healthcare systems on 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
Available Early Access Programs
Tofersen is an antisense asset being evaluated for the potential treatment of SOD1-ALS. In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observed. Based on totality of the data from the VALOR Phase 3 study and its open-label extension, Biogen is actively engaging with regulators, the medical community, patient advocacy groups and other key stakeholders around the world to determine potential next steps.
Additionally, in light of the critical unmet need, Biogen has expanded eligibility for its ongoing early access program (EAP) to all people with SOD1-ALS, in countries where such programs are permitted by local regulations and future access may be secured. EAP programs enable patients to gain access to a medicine free of charge before the treatment is licensed commercially. If a clear path forward for tofersen is not established, or if another controlled trial is required by regulators, Biogen may revise or discontinue the EAP.
In some countries, the expanding eligibility for the EAP will also change the regulatory mechanism used to provide access. In those cases, there may be actions required by the Treating HealthCare Professional (HCP) on behalf of patients already enrolled in an existing limited EAP. Biogen will work with Clinigen to support these Treating HCPs if local regulations require changes.
Treating healthcare professionals (HCPs) can submit requests on behalf of patients who meet the inclusion/exclusion criteria by emailing MedicineAccess@clinigengroup.com.
Update as of June 14, 2022:
Alzheimer’s: Aducanumab (outside of the United States only)
Aducanumab is an Alzheimer’s disease treatment approved in the United States (U.S.) under the accelerated pathway based on reduction in amyloid beta plaques observed in patients treated with aducanumab. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Aducanumab is still under review in some countries outside of the U.S. Making aducanumab available to qualified patients through regulatory approval is one of our top priorities.
Biogen recognizes the high unmet medical need of Alzheimer’s disease patients in countries where aducanumab is not yet approved. As we work with regulatory authorities, we are committed to offering access programs for eligible patients, where permitted by local regulations. There are currently two potential early access pathways to aducanumab for appropriate patients in some countries outside of the U.S. (early access to aducanumab is not available in the United States as the product is commercially available): an Early Access Program (EAP) and an International Pharmacy in number of countries/territories.We are working to assess the feasibility of the implementation of these programs on a country-by-country basis.
Effective April 22, 2022, Biogen has withdrawn its Marketing Authorization Application (MAA) for aducanumab from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) following interactions with CHMP indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA.
As a result, the Aducanumab Early Access Program is closed in countries in the European Union that fall under the EMA jurisdiction and no new requests for access to aducanumab will be accepted in those countries.
Biogen will continue to advocate for patients and remains committed to research and development working towards the goal of bringing new treatment options to people living with Alzheimer’s disease.
All access programs are subject to local regulatory and health authority requirements and a patient’s physician is responsible for deciding if treatment with aducanumab is appropriate.
For information regarding the availability, access, and timing of these programs, a patient’s treating physician can send an email to firstname.lastname@example.org.
How to Submit a Request
All requests must be submitted by a physician on behalf of the patient. All requests are considered in a fair and just manner in accordance with our guiding principles. However, please understand that submitting a request does not guarantee access will be granted.
Outside of the United States, search for your country information here.
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