by Jim Shamp, NCBiotech Writer
Workers at Biogen’s huge Research Triangle Park biopharmaceutical manufacturing site at 5000 Davis Drive are producing the initial supplies of the Alzheimer’s treatment newly approved by the U.S. Food and Drug Administration.
The Cambridge, Massachusetts-based company has two sites in RTP, the largest of which houses 1,600 workers. That’s where the company produces ADUHELM (aducanumab-avwa) for use in clinical trials and, now, the initial launch supply.
Ultimately Biogen officials expect the RTP production will be augmented by its plant in Solothurn, Switzerland.
Biogen and Eisai jointly announced that the FDA granted the accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in more testing.
The accumulation of amyloid beta plaques in the brain is a defining pathology of Alzheimer’s disease.
Biogen also announced several initiatives intended to support access to ADUHELM for eligible patients, and to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment. Another major North Carolina company, LabCorp, is part of that mix, which includes:
- Biogen Support Service Coordinators are now available at 1-833-425-9360 to provide one-on-one support. The service coordinators can answer questions about Alzheimer’s disease and ADUHELM treatment, assess financial assistance 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 cerebrospinal fluid diagnostic laboratory testing to aid in the diagnosis of Alzheimer’s disease.
- Working to finalize a multi-year agreement with the Veterans Health Administration (VHA) to support access for veterans throughout the VHA system.
- Entered into an initiative with CVS Health focused on the importance of brain health, screening and disease education. As part of this effort, cognitive screenings will be available through CVS Health’s Project Health, a longstanding health services program helping address care disparities for uninsured and underinsured Americans, particularly in racially and ethnically diverse communities. The program is scheduled to being in September in 14 cities.
- Working with The National Association of Free and Charitable Clinics (NAFC), a nationwide network of 1,400 clinics that focuses on ensuring the medically underserved have access to affordable quality health care. Together, we plan to develop a program that supports brain health and culturally competent Alzheimer’s disease education for patients and healthcare providers within the NAFC member clinic network.
- Offering co-pay and infusion cost assistance programs for qualified, commercially insured ADUHELM patients that may reduce out-of-pocket costs to as low as $0.
- Biogen and Cigna intend to enter a value-based contract to ensure that there is a streamlined path to access treatment for patients consistent with the population in which ADUHELM was studied.
Oprindelig kilde: WRAL TechWire