FDA Policy/General

Alnylam Pharma’s Web Promo is Misleading: FDA

FDA has issued an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra. In the letter, CDER’s Office of Prescription Drug Promotion said the Amvuttra Web page overstated the drug’s survival benefit in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), a serious and often fatal condition. The agency concluded that the promotional materials “misbrand” the drug, which is a violation of the Federal Food, Drug, and Cosmetic Act.

At issue are prominent claims on the Web page asserting that Amvuttra was “proven to help people with ATTR-CM live longer” and that patients “lived longer with continued treatment.” FDA said these statements create a misleading impression of a definitive and quantified mortality benefit.

The agency’s concerns center on how Alnylam presented data from the HELIOS-B study, particularly results from an open-label extension phase. While the pivotal trial itself was a randomized, double-blind, placebo-controlled study, the extension allowed patients previously on placebo to switch to Amvuttra, eliminating a concurrent control group.

According to FDA, this design introduces bias and confounding factors that make it difficult to draw firm conclusions about long-term survival outcomes. As a result, the agency said the data cannot support claims suggesting a clear reduction in mortality risk over 3½ years, including highlighted figures such as a “36% lower risk of death” or improved survival rates versus placebo.

FDA also noted that while the Web page included a disclaimer acknowledging limitations of the analysis, that language was insufficient to offset what the agency views as misleading efficacy claims.

Given the seriousness of ATTR-CM and the potential for patients to rely on promotional information when making treatment decisions, FDA said the violations raise public health concerns. The agency has asked Alnylam to take immediate corrective action, including ceasing dissemination of the misleading promotional materials. The company must respond within 15 working days, outlining steps to address the violations and identifying other promotional communications that may contain similar claims.

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