Benlysta Decision Likely To Be Delayed By Negotiations On Labeling
The Arthritis Advisory Committee's call for FDA to tailor labeling to restrict claims of efficacy to the clinical trial population for Human Genome Sciences' lupus drug Benlysta (belimumab) will likely push a decision on the drug beyond its Dec. 9 user fee date.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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