BridgeBio Pharma has declined to participate in the National Advertising Division’s (NAD’s) investigation into complaints made by Pfizer, leading the self-regulatory body to refer the case to federal agencies.
Pfizer and BridgeBio both sell treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). The NAD began looking into BridgeBio’s promotion of ATTR-CM medicine, Attruby, after Pfizer accused its rival of making misleading claims. The case centered on whether BridgeBio made express and implied claims that Attruby is superior to Pfizer’s Vyndamax because it offers greater TTR stabilization rates.
BridgeBio declined to participate in the self-regulatory process, leading the NAD to refer the case to the appropriate government agencies and to some platforms on which BridgeBio’s ads appeared.
“The NAD is a voluntary, non-regulatory body that has no authority over FDA-regulated products or advertising,” the company told Fierce Pharma Marketing in a statement. “BridgeBio has chosen not to participate in this process because it is a voluntary, private forum without jurisdiction over FDA-regulated communications.”
BridgeBio said Pfizer’s filing of a complaint with the NAD “is an attempt to bypass the FDA, the federal agency responsible for overseeing prescription drug advertising, and to challenge promotional materials which have already been through the proper regulatory processes.” That is “problematic,” according to the statement.
“Rather than competing on the strength of its data, Pfizer has chosen to use its market power and resources to create procedural distractions in an attempt to limit patients’ and physicians’ access to accurate information about these medications,” the company said, going on to allege that Pfizer hired the NAD’s former head and paid “a substantial fee” to bring the filing forward.
While Pfizer cited correspondence with the FDA to support its challenge, BridgeBio said in its statement that Attruby is the only ATTR-CM drug with near-complete stabilization in its FDA-approved prescribing information, adding that a German court recently ruled Pfizer must stop using “near-complete stabilization” to describe its therapy after finding the claim was unsupported by its data and label.
A spokesperson for Pfizer refuted the claim about the German court. The spokesperson said the German courts have upheld an injunction filed by Pfizer against Bayer, which commercializes acoramidis in Europe under an exclusive licensing agreement with BridgeBio, asserting that there is no evidence to support superiority of one therapy over another and that the Vyndaqel label states that the drug stabilizes TTR without any limitation.
"Contrary to BridgeBio’s statements, Pfizer has not been prohibited from using the claim 'near complete stabilization' in Germany and continues to use the statement with appropriate contextualization," the Pfizer spokesperson said.
BridgeBio’s refusal to participate in the NAD process follows a similar decision by Maze Therapeutics. In both cases, large biopharma companies went through the NAD to challenge claims made by an established or up-and-coming rival.
Pfizer’s challenge comes amid a fight for the ATTR-CM market. Having initially had a monopoly, Pfizer now faces competition from BridgeBio and Alnylam.
BridgeBio reported $108.1 million in U.S. Attruby net product revenue in the third quarter, up from $71.5 million in the second quarter. Meanwhile, sales of Pfizer’s Vyndaqel family of products, which includes Vyndamax, increased (PDF) 10% in the third quarter, but the company relied on international markets for growth, as Vyndaqel family sales fell 1% in the U.S.
Editor’s note: The story was updated Nov. 11 at 3:45 a.m. ET to add a statement from Pfizer.