FDA narrows guidance on controversial Alzheimer’s drug
pharmafile | July 9, 2021 | News story | Medical Communications |
A month after the approval of Biogen’s controversial new Alzheimer’s drug, Aduhelm, the FDA has narrowed its guidance on who should be treated with the drug.
The updated guidance from the approving body says that treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, as there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.
This is a significant change from the information given on the controversial drug prior, which stated that it was suitable for anyone suffering from the disease.
Alfred Sandrock, Head of Research and Development at Biogen, said, “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three ADUHELM clinical trials that supported approval.
“We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”
When the drug was first approved, a top FDA official told reporters that the drug was “relevant to all stages of Alzheimer’s disease.”
The drug’s approval has garnered much criticism, from FDA panel members, experts, and members of the public. Many say the data is unclear at best as to whether the drug actually works, and that its hefty price tag of $56,000 a year is a way for Biogen to make money from people desperate to find a cure for the disease.
One FDA panel member, Dr Aaron Kesselheim, who resigned in the wake of the approval, called it the “worst drug approval in recent US history”.
Biogen is required to show verification of clinical benefit in confirmatory trials to sustain continued approval for the drug.