Aduhelm’s Revised Labeling Could Help Payers Navigate Reimbursement

The US FDA revised labeling to clarify the target population, which could be helpful in reimbursement discussions for the Alzheimer's therapy.

compass
Revised labeling for Aduhelm could help payers and physicians navigate the treatment landscape • Source: Alamy

The US Food and Drug Administration has revised labeling for Biogen, Inc.'s Aduhelm (aducanumab) to better clarify how it should be used in Alzheimer's patients one month after the drug was approved in the US and following some backlash from legislators, physicians and health care spending watch dogs. The new language could help balance potential broad use and a high price tag in payer negotiations.

The updated labeling was announced on 8 July, updating the indication section to better clarify that the drug should be...

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

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

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.

More from Therapy Areas

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.