As Novartis (NVS) geared up to win approval for a new eye medication that was pegged to become a blockbuster, an employee tried to push the company to disclose incorrect safety data and claims she was fired for her trouble. And at the heart of the dispute is the same drug about which a leading association of eye physicians raised serious safety concerns to its members earlier this week.
In a lawsuit filed last year, Zuhal Butuner described how she suggested in March 2018 that Novartis either issue a press release or send letters to doctors about a “material error” in published safety data concerning Beovu, which was being developed to treat wet age-related macular degeneration. The medicine was approved last October by the Food and Drug Administration.
The data allegedly indicated the rate of stroke and heart attacks for the Eylea eye treatment sold by Regeneron Pharmaceuticals (REGN) was double the rate for the Novartis drug when, in fact, the rates were comparable. Butuner also sought to fix a “material omission” in published data that ocular inflammation rates exceeded rates found in Eylea and that Novartis had known this for a year.
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