NICE Downs GSK’s Benlysta In Second Lupus Indication On Comparator Grounds
This article was originally published in The Pink Sheet Daily
In yet another knock-back of GSK’s lupus drug Benlysta in the U.K., NICE said cost and comparator issues were not adequately addressed by the British manufacturer.
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NICE says GSK did not adequately compare its lupus drug belimumab to Roche’s Mab Thera (rituximab). While the firm and partner Human Genome Sciences did offer data that appeared to show an advantage, the problem is that the positive results were more prevalent in a patient population that did not broadly reflect the make-up of the U.K., NICE said.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
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