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Pacira's Exparel Adds Nerve Block Indication For Shoulder Surgery In US

 
• By Sue Sutter

In unusual move, labeling lists data supporting use as nerve block as well as other trials that 'do not support' a broader nerve block indication beyond brachial plexus; labeling includes data on reduced opioid use but notes clinical benefit has not been established.

X-ray of a sore shoulder

The US FDA's unusual approach to a labeling expansion for Pacira Pharmaceuticals Inc.'s local anesthetic Exparel suggests a balancing of the agency's desire to increase availability of non-opioid analgesics while guarding against promotion and use for a broader-than-supported indication.

On April 6, FDA approved the use of Exparel (bupivacaine liposome injectable suspension) as an interscalene brachial plexus nerve block

The indication is narrower than the general nerve block claim sought by Pacira

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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.

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