ADDF’s Fillit On FDA’s Tough Aducanumab Decision, Advances In Alzheimer’s

New Blood Test Should Aid Drug Trials, Symptomatic Treatments Advancing

The pending US FDA decision on Biogen’s drug overshadows progress in Alzheimer’s diagnosis, symptomatic treatments and the need to keep studying anti-tau therapies after Roche’s setback.

Alzheimer's disease on MRI
Brain imaging biomarkers are contributing to better Alzheimer's disease diagnosis and more efficient drug development • Source: Shutterstock

The US Food and Drug Administration has a difficult decision to make regarding whether or not to approve Biogen, Inc.’s amyloid-targeting antibody aducanumab, Alzheimer’s Drug Discovery Foundation founding executive director and chief scientific officer Howard Fillit said, but while that is dominating the near-term Alzheimer’s discussion, there’s other progress being made.

Scrip spoke with Fillit about Biogen’s closely watched therapeutic candidate, which is developing in partnership with Eisai Co., Ltd.,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By 

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By 

Oral RNA splicing modulator has gone into a Phase II/III trial

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

Supernus Secures Sage With CVR-Supported Deal

 

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

More from Therapy Areas

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By 

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.