The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.
The company’s stock dropped 6.79% to $328.16.
After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials.
FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug.
Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.
The Institute for Clinical and Economic Review (ICER) has concluded that there is insufficient data to support the drug’s $56,000 per year price tag. Biogen has criticized the analysis.
The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment at an external facility.
The institution indicated that it could change its mind about the biologic Aduhelm after more data become available.
Biogen plans on offering assistance to patients who have trouble receiving the drug, which it developed in partnership with Eisai (TYO:4523).
The Alzheimer’s Association, which supported FDA’s approval of the drug, has called for “timely” and “equitable” patient access to the drug. The organization recently released a statement recommending that CMS consider a National Coverage Determination (NCD) for the drug. According to the organization, an NCD can “help prevent regional and community level disparities” of access to aducanumab.
Analysts have generally been upbeat about Biogen’s neurodegenerative disease strategy and its competitive standing in the area.
The company’s focus on biologics has proven profitable in the past. All of the company’s blockbusters, apart from the multiple sclerosis therapy Tecfidera are biologics.
Filed Under: Drug Discovery, Neurological Disease