Trading in Biogen (BIIB) – Get Report The drugmaker was stopped Friday before a meeting of the US Food and Drug Administration Advisory Committee on the Treatment of Experimental Alzheimer’s Disease.
The FDA panel of outside consultants will discuss whether aducanumab is an effective treatment for Alzheimer’s disease and whether to recommend drug withdrawal.
The FDA is not required to follow the advice of an advisory committee, but it usually does.
The panel has been the source of some controversy after the FDA re-appointed a member citing a conflict of interest.
Mayo Clinic neurologist David Knopman confirmed to Reuters on Monday that he had been removed from the scheduled meeting.
Knopman, who said he was reused because of his involvement in conducting clinical trials of aducanumab, has criticized the drug, including a paper published Sunday in the Alzheimer’s & Dementia Journal, Reuters reported.
Biogen shares rose on Wednesday after they were found effective enough in a large trial in support of FDA panel approval.
According to Bloomberg, FDA staff said in a study on Wednesday that the drug’s effect is “strong and exceptionally persuasive.”
If approved, educanumab could be a multibillion-dollar seller, analysts told Reuters. The FDA has not reviewed an application for a new Alzheimer’s treatment since 2003.
Aducanumab is important for biogen. Last month, the company downgraded its full-year guidance, saying that generic versions of its Techfidera multiple-sclerosis treatment had cut sales.
Biogen has stated that educanumab was shown in one of two major studies to significantly slow the decline of cognition and function.
A second trial, however, showed benefit only for a subset of patients who had been given high doses for at least 10 months, Reuters said.
Biogen on the drug halted clinical trials in March 2019 after determining that educanumab was unlikely to work. This was reversed in October after more data was reviewed and it was announced that one of the two tests had been successful.
Biogen is developing the drug jointly with Japanese pharmaceutical company Eisai (ESALY) .
Biogen stock closed down 7.5% at $ 328.90 on Thursday.