The Food and Drug Administration gave the green light to a controversial new Alzheimer’s drug — despite objections from some of its own experts, according to internal memos made public Tuesday.
The federal agency’s drug statistics office had raised concerns that there wasn’t enough clinical trial data proving Biogen drug’s was effective, The Wall Street Journal reported.
The FDA’s drug biostatistics office “provided documentation for its recommendation that substantial evidence of effectiveness had not been provided in the application,” one of the memos stated, according to the report.
Another document shows that Tristan Massie, biostatistics reviewer for the agency, “does not agree that the totality of the data provides sufficient evidence to support the efficacy of aducanumab in Alzheimer’s disease and does not recommend approval.”
In a memo detailing his support for approval, Peter Stein, the director of the FDA’s office of new drugs, acknowledged that the agency was “faced with a situation where the available evidence on the clinical endpoints is short of what we would require for standard approval of aducanumab.”
“At the same time, patients with [Alzheimer’s] have a serious, progressive, ultimately fatal disease and are desperate for treatments,” Stein added, according to the report.
The 83 pages of memos detailing some of the FDA’s internal deliberations were made public by the agency, which has been facing some backlash over its June 7 decision to approve the drug, which will be marketed as Aduhelm.
Some doctors and scientists have raised questions about the cost and effectiveness of the medication, the first federally approved treatment for Alzheimer’s in about 18 years. Three scientists on a panel advising the FDA reportedly resigned after the drug’s approval.
Ultimately, the agency’s top-ranking drug-evaluation official, Dr. Patrizia Cavazzoni, wrote that Biogen had met the requirements for an “accelerated approval.”
The drug had met that standard, Cavazzoni wrote, because it can reduce accumulated beta amyloid, a protein many researchers believe plays a significant role in Alzheimer’s disease.
Biogen still has to complete a large clinical trial to confirm that removing the beta amyloid has benefits when it comes to cognitive decline in patients, the FDA said. The agency can still rescind approval if the results of that study are lackluster.