1/ BLAMING THE PATHWAY?
tinyurl.com/dp5t5njh
@AlzResearchUK tries to explain why EMA didn't approve #aducanumab as @US_FDA did. It seems to suggest that the lack of an accelerated approval pathway at EMA is the problem @ProfRobHoward @pash22
tinyurl.com/dp5t5njh
@AlzResearchUK tries to explain why EMA didn't approve #aducanumab as @US_FDA did. It seems to suggest that the lack of an accelerated approval pathway at EMA is the problem @ProfRobHoward @pash22
2/ "The FDA approved aducanumab via its Accelerated Approval Pathway. This means a licence can be granted based on a drug’s effect on a biological marker of disease, rather than its proven ability to improve people’s day-to-day lives. This meant the FDA was able to consider
3/ #aducanumab’s effect on amyloid levels in the brain, rather than how it affected people’s memory and thinking. The EMA does not have a similar pathway to approval. Under its pathway, its committee considered whether the trial results showed evidence that the drug
4/ was safe for use, and whether it was able to effectively slow the decline in people’s memory and thinking."
Kudos to the EMA for basing the decision on the ability of the Rx to make a difference in patient's lives & their memory & thinking. It is the standard patients deserve.
Kudos to the EMA for basing the decision on the ability of the Rx to make a difference in patient's lives & their memory & thinking. It is the standard patients deserve.
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