- Biogen shares fell as much as 8% after two major hospital systems said they would not prescribe the controversial Alzheimer’s drug, Aduhelm.
- According to a New York Times report, the Cleveland Clinic and Mt. Sinai said it would not prescribe the drug to patients.
- Aduhelm was approved by the FDA last month but lacked data demonstrating its effectiveness in preventing or slowing Alzheimer’s disease.
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Biogen fell 8% on Thursday after a New York Times report said two major hospital systems would not prescribe its controversial Alzheimer’s drug, Aduhelm.
Aduhelm was FDA approved last month in a controversial decision for the treatment of Alzheimer’s disease. Pressure from patients and their families desperate for an Alzheimer’s drug compensated for the lack of data demonstrating the effectiveness that the drug prevents or slows the progression of the fatal disease.
According to the Times, the Cleveland Clinic and Mt. The Sinai hospital systems will not prescribe Aduhelm to patients.
The Cleveland Clinic said in a statement that after reviewing all available safety and efficacy data on the drug, “we have decided not to offer aducanumab at this time.”
The Cleveland Clinic said individual doctors in the hospital network could prescribe Aduhelm to patients, but patients would have to go elsewhere to receive the drug, which is given as a monthly intravenous fusion, the Times reported.
Meanwhile, the director of Mt. Sinai Center for Cognitive Health, Dr Sam Gandy said he would not administer Aduhelm as he were calls for a federal investigation review the FDA approval decision and the agency’s relationship with Biogen.
“Aduhelm will not be considered for an infusion in patients on any of its campuses until and unless” an investigation by the Inspector General of the Department of Health and Social Services “affirms the integrity of the FDA / Biogen relationship and reaffirms “the basis of the FDA for approving the drug,” the Times reported.
In a response to The Times, Biogen said it supports the data used in the FDA approval of Aduhelm and that “if a patient is denied access to care, we encourage them to contact us for further advice. help as we remain committed to supporting access to Aduhelm for all appropriate patients. “
Biogen’s decision to price Aduhelm at $ 56,000 per year has put political pressure on the company, as some view the price as obscene as scientific data does not demonstrate its effectiveness in treating the disease. Alzheimer’s disease.
The next hurdle for Biogen will be getting approval from health insurers to cover the costs of the drug. So far, UnitedHealth Group has said in a recent earnings call that it has yet to decide whether or not to cover the drug.
Biogen shares are still up 32% year-to-date, but are down 31% from its June 7 peak of $ 468.55.