Oct. 2 at 3:49 PM
Alnylam Pharmaceuticals has halted a TV advertisement for its cardiac drug Amvuttra after receiving a warning letter from the FDA. The letter, dated September 9, stated that the ad was misleading because it depicted patients engaging in activities such as whale watching and cheering at football games, suggesting that the drug broadly improves quality of life—a claim not supported by clinical evidence.
George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, noted that the ad implied patients “can be carefree” about their cardiac condition and could experience wide-ranging life improvements that have not been demonstrated.
Alnylam maintains that its promotional materials are “truthful, not misleading, and comply with applicable FDA requirements,” but the company has suspended the TV ad while reviewing the agency’s feedback.
$ALNY