FDA calls out Incyte’s Niktimvo efficacy claims on branded website

The FDA has issued an SMR letter to Incyte regarding misleading promotional claims for its cGVHD treatment, Niktimvo. Regulators argue that statements on the drug’s branded website, such as those about “fast and lasting responses” and organ-level benefits, overstate the efficacy supported by clinical data. This action follows a previous SMR letter to Incyte six months Prior to this, indicating a pattern of concern regarding their promotional practices.

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