- Biogen has filed findings for its Alzheimer's clinical trial with the FDA
- A landmark case for US regulators and their first major test under the Biden administration
The successful results reported by US pharma group Biogen (US: BIIB) in the clinical study of its Alzheimer’s drug aducanumab have been compared to “firing a shotgun at a barn door and then drawing a target around the bullet holes.”
It’s not a completely unfair criticism. Scientists working on the clinical trial initially concluded that it had been unsuccessful in slowing the progression of Alzheimer’s Disease - the leading cause of dementia - before retracting their early comments after finding that patients who had been given a higher dosage showed good signs of progress. A subsequent trial found that aducanumab has the potential to slow the underlying disease pathology and cognitive decline in patients with mild symptoms.
Biogen has filed its findings with the US Food and Drug Administration (FDA) who are expected to make a decision today.
It is a landmark case for the US regulators who have never before approved a drug to combat the underlying cause of Alzheimer’s disease. Indeed, treatments to slow the progression of most neurological conditions fail long before the pharma companies can make their submissions to the FDA.
The case is also significant as it is the first major test for the FDA under the Biden administration. Market commentators think the decision will be a barometer for how strict the agency will be in the coming years.
And beyond the immediate impact for Biogen, the FDA’s decision could have long-lasting repercussions for the wider pharma industry. A positive decision might signal a loosening of the regulatory environment, paving the way to a different type of clinical trial - one where targets can be set after the initial shots have been fired.