The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen's stock rose 10%, but analysts had mixed opinions.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug's clinical benefit.
The biotech company said in its first quarter 2020 earnings that it would complete the submission of its Food and Drug Administration filing for aducanumab in the third quarter. An analyst wrote that it means the agency wouldn't likely complete its review until after the presidential election.
Shares of the biotech company were up following the presentation on the drug, aducanumab, but investment bank analysts continued to raise questions about its future, particularly its prospects of FDA approval.
In a note to investors, Baird analyst Brian Skorney harshly criticized Biogen's decision to seek FDA approval for aducanumab, an amyloid beta-targeting drug whose development it had previously halted after an analysis indicated its clinical trials would fail.
The company said a subsequent analysis of the Phase III studies of aducanumab, which it had stopped for futility in march, showed that one of them had been successful. A filing with the FDA is planned for early 2020.
Biogen halting its Phase III trial of aducanumab last month had many proclaiming the amyloid beta hypothesis' demise. But many doctors soldier on, while others see potential alternative uses for Abeta-targeting drugs.
The news sent Biogen's shares down more than 26 percent pre-market, but analysts also wrote that it deals a significant blow to amyloid beta as a target in Alzheimer's disease.
