The Institute for Clinical and Economic Review (ICER) on Wednesday, Aug. 7, said recent issues with animal testing data for Novartis’ Zolgensma will not require an updated review of the initial assessment.
The drug pricing watchdog’s statement comes on the heels of the Food and Drug Administration’s (FDA) announcement that Novartis informed the agency about a data manipulation issue involving animal testing for the drug.
“[ICER] is deeply concerned about issues related to data integrity, and we are monitoring the situation closely,” ICER said in a statement. ” … If additional investigations reveal that data from the human trials also were compromised in any way, ICER will issue an update to our earlier assessment.”
To read the FDA’s announcement on the matter, click here.