Alnylam Pharmaceuticals Inc. has stopped airing a television commercial for its heart medicine Amvuttra following regulatory scrutiny, after it received a warning letter from the U.S. Food and Drug Administration.
The letter, sent September 9th, claimed the company’s commercial was misleading because it showed patients engaging in activities like whale-watching and cheering enthusiastically at football games.
George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research, wrote that the ad incorrectly suggested patients "can be carefree" about their heart condition and "misleadingly suggests that treatment with Amvuttra will broadly improve a patient’s overall quality of life when this has not been demonstrated."
Alnylam maintains that its promotional materials are "truthful, non-misleading, and comply with applicable FDA requirements" but has discontinued the television ad while reviewing the agency’s comments.
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