RESEARCH TRIANGLE PARK – Workers of Biogen ‘The massive Research Triangle Park biopharmaceutical manufacturing site at 5000 Davis Drive produces the first supplies for the treatment of Alzheimer’s disease newly approved by the United States Food and Drug Administration.

The Cambridge, Massachusetts-based company has two sites at RTP, the largest of which houses 1,600 workers. This is where the company produces ADUHELM (aducanumab-avwa) for use in clinical trials and, now, the initial launch supply.

Ultimately, Biogen officials expect production of RTP to be increased by its plant in Solothurn, Switzerland.

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Biogen and Eisai jointly announced that the FDA has granted expedited approval based on the reduction in beta-amyloid plaques seen in patients treated with ADUHELM. Continued approval for this indication may depend on verification of clinical benefit in more trials.

The accumulation of beta-amyloid plaques in the brain is a determining pathology in Alzheimer’s disease.

Biogen also announced several initiatives to support access to ADUHELM for eligible patients, and to help patients and their families understand the disease, navigate the diagnostic journey, ensure culturally appropriate care, and pay for treatment. . Another large North Carolina company, LabCorp, is part of this mix, which includes:

• Biogen Support Coordinators are now available at 1-833-425-9360 to provide one-on-one assistance. Service coordinators can answer questions about Alzheimer’s disease and ADUHELM treatment, assess financial aid options for eligible patients, and locate healthcare providers and infusion sites, among other topics.
• Established a program with LabCorp and Mayo Clinic Laboratories to help physicians and patients access diagnostic laboratory tests of cerebrospinal fluid to aid in the diagnosis of Alzheimer’s disease.
• Work to finalize a multi-year agreement with the Veterans Health Administration (VHA) to support veterans access throughout the VHA system.
• Participated in an initiative with CVS Health focused on the importance of brain health, disease screening and education. As part of this effort, cognitive screens will be available as part of CVS Health’s Project Health, a long-standing health services program helping to address disparities in care for uninsured and underinsured Americans, especially in diverse racial and ethnic communities. The program is scheduled for September in 14 cities.
• Work with the National Association of Free and Charitable Clinics (NAFC), a national network of 1,400 clinics that aims to ensure that medically underserved people have access to affordable, quality health care. Together, we plan to develop a program that supports brain health and culturally relevant education about Alzheimer’s disease for patients and healthcare providers within the network of NAFC member clinics.
• Offer co-payment and infusion cost assistance programs for qualified and commercially insured ADUHELM patients that can reduce out-of-pocket expenses to as little as $ 0.
• Biogen and Cigna intend to enter into a value-based contract to ensure that there is a streamlined path to treatment for patients compatible with the population in which ADUHELM has been studied.

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