USA FDA Gives Biogen Big Hand In Effort To Get Its Alzheimer’s Treatment On The Market
In unusual move, FDA formed ‘working group’ collaboration with Biogen to conduct further analyses of two aducanumab studies after the Phase III trials were halted. Agency concluded drug’s effectiveness in one of the studies is ‘robust and exceptionally persuasive’ and advised Biogen that it was ‘reasonable’ to submit a marketing application.
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US FDA’s oncology chief says he won’t talk to sponsors unilaterally when a company takes issue with their review division. Pazdur also weighed in on his long-term career plans and his views on the FDA-industry revolving door at two ASCO interviews.
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
Peripheral and Central Nervous System Drugs Advisory Committee has held two of FDA’s most closely watched meetings in recent years, but there was little overlap between the panel that reviewed Amylyx’s ALS drug and the one that evaluated Biogen’s aducanumab 16 months earlier.