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Patient Support May Have Helped Push Aduhelm Toward Approval

 
• By Derrick Gingery

After largely negative advisory committee meeting, a patient group held a listening session with the FDA to be sure their voices were heard during the review of Biogen's aducanumab.

Alzheimer's brain scan and drugs
Aduhelm's approval could help drive clinical development of other Alzheimer's disease treatments. • Source: Alamy

After the US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee largely voted against Biogen, Inc.’s Alzheimer’s disease treatment Aduhelm (aducanumab) in November 2020, the Alzheimer’s Association took action, apparently to combat the negative sentiment.

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

More from Product Reviews

PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
• By Neena Brizmohun

PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts

 
• By Sue Sutter

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.