[ad_1]
Biogen shares fell on Friday after the chief of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.
Acting FDA Commissioner Dr Janet Woodcock has asked the agency’s Inspector General to investigate interactions between the US agency and representatives of Biogen ahead of the drug’s approval on June 7.
“I believe it is essential that the events in question be reviewed by an independent body such as the Office of the Inspector General to determine whether the interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures, “Woodcock wrote in a letter sent Friday.
Biogen actions fell by more than 3% after the announcement.
Biogen shares surged last month after the FDA approved the biotech company’s drug, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s disease and the first new drug for the disease in nearly two decades.
The move marked a break with the opinion of the agency’s group of independent experts, which unexpectedly refused to approve the drug last fall, citing unconvincing data. At least three panel members resigned in protest following the agency’s approval.
Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients, asking to speed up treatment of the drug, scientifically known as aducanumab. STAT News and other media reported that FDA officials used a regulatory shortcut to gain approval in order to bring the drug to market sooner.
Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists say plays a role in this devastating disease.
Rarely does an FDA chief ask for an investigation into the agency’s own decisions. This is the latest setback for the company and the drug, which has been controversial since showing promise in 2016.
In March 2019, Biogen halted development of the drug after an independent group analysis found it unlikely to work. The company then shocked investors several months later by announcing that it would ultimately seek regulatory approval for the drug.
When Biogen applied for drug approval in late 2019, its scientists said that new analysis of a larger data set showed aducanumab “reduces clinical decline in patients with Alzheimer’s disease. early “.
Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some questioning whether there was enough clinical trial data to prove the drug works and whether approval could make it harder for other companies to list. of patients in their own drug trials.
Some doctors have said they will not prescribe aducanumab due to the mixed data package supporting the company’s claim.
[ad_2]
Source link