Pfizer’s complaint about Alnylam’s activities at a cardiology congress has led the PMCPA to chastise the biotech, although the U.K. marketing watchdog overturned its severest criticism on appeal.
The case centered on alleged promotion at the European Society of Cardiology 2024 congress in London. Alnylam used the event to share information on Amvuttra, an RNAi therapy that, at the time, was weeks away from being submitted for approval in transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. Amvuttra was already approved for polyneuropathy caused by hereditary ATTR, or hATTR-PN.
Pfizer, which sells the rival ATTR therapy Vyndamax, complained to the PMCPA after talks with Alnylam failed to resolve its concerns about its rival’s activities at the congress. Pfizer alleged Alnylam promoted Amvuttra outside the scope of its marketing authorization. The allegations covered several parts of Alnylam’s presence at the meeting, including booth materials, an Alnylam-organized evening ATTR meeting and two tutorial sessions.
The PMCPA initially ruled that Alnylam had discredited the industry, its harshest censure, but overturned that conclusion on appeal.
Alnylam’s petition against that finding succeeded in part because it persuaded the PMCPA appeal board that one of the tutorials, a promotional session on treating hATTR-PN patients with a mixed phenotype, did not promote Amvuttra off-label. The appeal board concluded that discussions of cardiac manifestations in ATTR-PN patients during the tutorial didn’t fall outside the scope of Amvuttra’s licensed indication.
The appeal board reached a different conclusion about the Alnylam-organized evening ATTR meeting. It upheld the original ruling that Alnylam promoted Amvuttra outside the scope of its marketing authorization by presenting data on the drug in ATTR-CM, an indication that was not licensed at the time.
The appeal board said proactively providing data on a licensed drug in an unlicensed indication was likely to be considered promotional. Alnylam failed to persuade the appeal board that its presentation of Amvuttra data in ATTR-CM was an exception to that rule.
Because the appeal board upheld one ruling but overturned another, it reversed the finding that Alnylam had brought discredit upon, or reduced confidence in, the pharmaceutical industry. The appeal board considered that finding disproportionate, although it upheld the ruling that Alnylam had failed to maintain high standards by promoting Amvuttra for an unlicensed indication.
The ruling marks the end of a case that put Alnylam and Pfizer at loggerheads. In its response to the PMCPA, Alnylam accused Pfizer of cherry-picking information, conflating issues and pulling its activities out of context to create a misleading impression of the events. Pfizer’s allegations were “sweeping and unsubstantiated,” Alnylam said.
ATTR is a multibillion-dollar market. Alnylam reported Amvuttra sales of $890 million in the first quarter, with demand from ATTR-CM patients in the U.S. driving 187% growth. Vyndamax and related products generated (PDF) $1.6 billion for Pfizer in the first quarter. BridgeBio Pharma’s Attruby is also approved in ATTR-CM.