USA – The Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) have opened separate investigations into Biogen Inc and its Alzheimer’s medication, Aduhelm (aducanumab).
According to the Company’s annual filing, the FTC has issued a civil investigative demand for documents related to Aduhelm’s marketing and approval, as well as healthcare sites.
Meanwhile, the SEC has opened a separate investigation into the beleaguered anti-amyloid antibody, seeking marketing and approval information as well.
The lawmakers have also requested that the FDA provide additional data and documentation to support the drug’s accelerated approval.
The Securities and Exchange Commission (SEC) regulates the securities markets and works to protect investors.
The US Food and Drug Administration approved Biogen’s Aduhelm in June, making it the first Alzheimer’s treatment in decades, despite one of its two large-scale clinical trials failing to show a benefit to patients.
A panel of expert advisers voted against the drug, and some panel members resigned as a result.
In July, the FDA asked the Department of Health and Human Services’ Office of Inspector General to launch an investigation into interactions with Biogen related to the drug’s approval.
Legislators in the United States have also launched an investigation into the drug. Nonetheless, Aduhelm’s sales have been slow since its launch, and Biogen reduced the price by half in December.
Biogen and others anticipate that in order for Aduhelm to recover, it will require favorable coverage from Medicare, the government insurance program for people 65 and older.
However, some investors are skeptical that this will happen, especially after Medicare proposed a policy last month that would strictly limit which patients would be eligible to receive Aduhelm or other Alzheimer’s drugs that work in a similar fashion.
Biogen is now campaigning to change Medicare’s position before the policy is finalized in April.
Aduhelm’s rocky launch has also resulted in low sales. According to Biogen, the drug only made US$1 million in the fourth quarter and US$3 million for the entire year of 2021.
That pales in comparison to the hundreds of millions of dollars in selling, general, and administrative expenses incurred by the company so far on the beleaguered medicine.
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