Friday, 18 Aug 2017

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Therapeutic Update: 5 Questions on Sirukumab FDA Hearing

Therapeutic updates are periodic reports that feature commentary, insight and review from leading experts on advances in therapeutics in rheumatology. These updates may feature new drug approvals or indications; product label or safety updates, new important clinical trial results, new treatment guidelines or disease management reviews. 

In this Therapeutic Update Drs. Cush and Gibofsky answer 5 questions about the August 2, 2017 FDA Arthritis Advisory Committee meeting that reviewed the NDA for sirukumab use in rheumatoid arthritis. While the panel unanimously (13-0) acknowledged the efficacy of sirukumab, they ultimately voted against (1-12) the approval of sirukumab, pointing to safety concerns and the data showing a higher number of in all-cause mortalities in sirukumab treated patients.  

 

 

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Rheumatologists' Comments

a great discussion on FDA approach.Why not do one on Romosozumab which -in contrast-is both first in class and phenomenally effective.Tony Russell

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