Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
The Alzheimer’s Association has welcomed the FDA’s approval of aducanumab for Alzheimer’s disease, calling it ‘the beginning of a completely new future for Alzheimer’s treatments’.
Biogen pledges to share future insights about Aduhelm (aducanumab-avwa) with the scientific community as it collects more data from real-world use of the treatment, after the drug was approved by the FDA yesterday.
The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.
Biogen Inc’s shares tumbled around 30% yesterday with the company hitting a roadblock late last week as it chases regulatory approval for its investigational Alzheimer's treatment.
Research into Alzheimer’s disease is suffering from a chronic lack of investment, after clinical trial failures across the field, a report by BIO suggests.
Biogen will halt all clinical trial activity on its Alzheimer’s drug, aducanumab, after its failure in Phase III trials, according to its first quarter financials.
Biogen and its partner, Eisai, confirm a decision to stop the Phase III development of aducanumab, a potential treatment for Alzheimer’s – a key part of the former’s pipeline.
In another blow to discovering a treatment for Alzheimer’s, Roche revealed that preliminary data from two clinical trials meant it was cancelling studies using crenezumab.
Reaching the central nervous system is a difficult task, and getting a high enough dose to it poses an issue as well, but innovations are well underway to bridge a path across the blood-brain barrier.
